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Natural History Study in Subjects With Usher Syndrome ((USH1B) is a multi-centre, longitudinal, observational study designed to evaluate disease progression in subjects with USH1B by several vision-related assessments.
Natural History Study in Subjects With Usher Syndrome (USH1B) is being conducted to understand the progression of disease in USH1B patients as measured by visual acuity and visual field testing and a number of other vision-related assessments. Disease progression will be evaluated as change over time in these measures and associations between the endpoints will be examined.
The primary objective of this study is to evaluate the natural progression of disease over time in USHIB patients using visual field testing and best corrected visual acuity.
The secondary objectives of this study are to evaluate the progression of disease over time in USHIB patients through additional assessments:
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| Measure | Description | Time Frame |
|---|---|---|
| BCVA - Better Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the better-seeing eyes. BCVA in the better seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in ETDRS score collected at the 1 year follow-up visit compared with the score at the baseline visit. | 1 year follow up visit |
| BCVA - Better Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the better-seeing eyes. BCVA in the better seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in ETDRS score collected at the 2 year follow-up visit compared with the score at the baseline visit. | 2 year follow up visit |
| III4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the better seeing eyes. Visual field area using III4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| III4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the better seeing eyes. Visual field area using III4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 year follow up visit |
| V4e Area - Better Seeing Eyes |
| Measure | Description | Time Frame |
|---|---|---|
| MS - Better Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the better-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects affected by Usher Syndrome 1B disease fulfilled eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| FRANCESCA SIMONELLI | Eye Clinic of the University of Campania Luigi Vanvitelli, Naples, Italy | Principal Investigator |
| Ingeborgh van den Born | Stichting Oogziekenhuis Rotterdam, Rotterdam, The Netherland. | Principal Investigator |
| Carmen Ayuso | Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Clinic of the University of Campania Luigi Vanvitelli | Naples | Italy | ||||
| Stichting Oogziekenhuis Rotterdam |
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53 subjects meeting the inclusion/exclusion criteria were enrolled in the 18-month recruitment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group of Subjects With Usher Syndrome Type 1B | In this study, there is 1 group of subjects with Usher Syndrome type 1B enrolled, over the 18-month recruitment period, to evaluate disease progression by several vision-related assessments. Subjects will be assessed using the following schedule:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 61 patients (32 screened by Unicamp, 20 by IIS-FJD and 9 by REH) with clinical diagnosis of USH1 were screened for inclusion in the study. 8 of these were excluded according to exclusion/inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group of Subjects With Usher Syndrome Type 1B | In this study, there is 1 group of subjects with Usher Syndrome type 1B enrolled, over the 18-month recruitment period, to evaluate disease progression by several vision-related assessments. Subjects will be assessed using the following schedule:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BCVA - Better Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the better-seeing eyes. BCVA in the better seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in ETDRS score collected at the 1 year follow-up visit compared with the score at the baseline visit. | patients undergoing one-year follow-up visit | Posted | Mean | Standard Deviation | ETDRS score | 1 year follow up visit |
|
1 year, 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group of Subjects With Usher Syndrome Type 1B | In this study, there is 1 group of subjects with Usher Syndrome type 1B enrolled, over the 18-month recruitment period, to evaluate disease progression by several vision-related assessments. Subjects will be assessed using the following schedule:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development and Operations | Fondazione Telethon | +3902202217224 | szancan@telethon.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2018 | Jul 3, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2018 | Sep 29, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C536485 | Usher syndrome, type 1B |
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Change (from Baseline) in visual field area using V4e stimulus size in the better seeing eyes. Visual field area using V4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. |
| 1 year follow up visit |
| V4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the better seeing eyes. Visual field area using V4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 year follow up visit |
| BCVA - Worse Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the worse seeing eyes. BCVA in the worse seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in the ETDRS score collected at the 1 year follow-up visit compared with the score at the baseline visit. | 1 year follow up visit |
| BCVA - Worse Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity in the worse seeing eyes. Best corrected visual acuity in the worse seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in the ETDRS score collected at the 2 year follow-up visit compared with the score at the baseline visit. | 2 years follow up visit |
| III4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the worse-seeing eyes. Visual field area using III4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| III4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the worse-seeing eyes. Visual field area using III4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| V4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the worse-seeing eyes. Visual field area using V4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| V4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the worse-seeing eyes. Visual field area using V4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| MS - Better Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the better-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| CMT - Better Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the better-seeing eyes. CMT was reported in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| CMT - Better Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the better-seeing eyes. CMT was reported in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| EZ Band Horizontal - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the better-seeing eyes. EZ Band Horizontal is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| EZ Band Horizontal - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the better-seeing eyes. EZ Band Horizontal is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| EZ Band Vertical - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the better-seeing eyes. EZ Band Vertical is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| EZ Band Vertical - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the better-seeing eyes. EZ Band Vertical is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| MS - Worse Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the worse-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| MS - Worse Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the worse-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| CMT - Worse Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the worse-seeing eyes. CMT is expressed in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| CMT - Worse Seeing Eyes | Change (from Baseline) in Central Macular Thickness, evaluated with Optical Coherence tomography, in the worse-seeing eyes. CMT is expressed in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| EZ Band Horizontal - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the worse-seeing eyes. EZ Band Horizontal is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| EZ Band Horizontal - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the worse-seeing eyes. EZ Band Horizontal is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| EZ Band Vertical - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the worse-seeing eyes. EZ Band Vertical is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | 1 year follow up visit |
| EZ Band Vertical - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the worse-seeing eyes. EZ Band Vertical is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | 2 years follow up visit |
| Rotterdam |
| Netherlands |
| Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz | Madrid | Spain |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Count of Participants | Participants |
|
| Race (NIH/OMB) | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Count of Participants | Participants |
|
| Region of Enrollment | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion/exclusion criteria. | Number | participants |
|
| BCVA - better seeing eyes | Best Corrected Visual acuity in the better-seeing eyes. The ETDRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning) is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m). If fewer than 20 letters can be read at 4m, the patient's position is adjusted to 1m in front of the chart. | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion/exclusion criteria. | Mean | Standard Deviation | ETDRS Score |
|
| III4e Area - better seeing eyes | Visual field area using III4e stimulus size in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Degree Squared |
|
| V4e Area - better seeing eyes | Visual field area using V4e stimulus size in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Degree squared |
|
| MS - better seeing eyes | Macular sensitivity, assessed by microperimetry, in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Decibels |
|
| CMT - better seeing eyes | Central Macular Thickness, evaluated with Optical Coherence tomography, in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
|
| EZ Band Horizontal - better seeing eyes | Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
|
| EZ Band Vertical - better seeing eyes | Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (vertical scan), in the better-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
|
| BCVA - worse seeing eyes | Best Corrected Visual acuity in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | ETDRS score |
|
| III4e Area - worse seeing eyes | Visual field area using III4e stimulus size in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Degree squared |
|
| V4e Area - worse seeing eyes | Visual field area using V4e stimulus size in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Degree squared |
|
| MS - worse seeing eyes | Macular sensitivity, assessed by microperimetry, in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Decibels |
|
| CMT - worse seeing eyes | Central Macular Thickness, evaluated with Optical Coherence tomography, in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
|
| EZ Hor. - worse seeing eyes | Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
|
| EZ Vert. - worse seeing eyes | Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (vertical scan), in the worse-seeing eyes | As mentioned before, 61 patients were screened, but 53 patients were considered for analyses because 8 patients did not meet the inclusion criteria. | Mean | Standard Deviation | Micrometers |
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| Primary | BCVA - Better Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the better-seeing eyes. BCVA in the better seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in ETDRS score collected at the 2 year follow-up visit compared with the score at the baseline visit. | patients undergoing two-year follow-up visit | Posted | Mean | Standard Deviation | ETDRS score | 2 year follow up visit |
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| Primary | III4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the better seeing eyes. Visual field area using III4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 1 year follow up visit |
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| Primary | III4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the better seeing eyes. Visual field area using III4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 2 year follow up visit |
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| Primary | V4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the better seeing eyes. Visual field area using V4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 1 year follow up visit |
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| Primary | V4e Area - Better Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the better seeing eyes. Visual field area using V4e stimulus size in the better seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 2 year follow up visit |
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| Primary | BCVA - Worse Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity (BCVA) in the worse seeing eyes. BCVA in the worse seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in the ETDRS score collected at the 1 year follow-up visit compared with the score at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | ETDRS score | 1 year follow up visit |
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| Primary | BCVA - Worse Seeing Eyes | Change (from Baseline) in Best Corrected Visual acuity in the worse seeing eyes. Best corrected visual acuity in the worse seeing eyes was assessed using the ETRS score (minimum value 0 and maximum value 100, with 0 representing the worst, and 100 the best visual functioning). The results are reported as the change in the ETDRS score collected at the 2 year follow-up visit compared with the score at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | ETDRS score | 2 years follow up visit |
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| Primary | III4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the worse-seeing eyes. Visual field area using III4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 1 year follow up visit |
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| Primary | III4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using III4e stimulus size in the worse-seeing eyes. Visual field area using III4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 2 years follow up visit |
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| Primary | V4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the worse-seeing eyes. Visual field area using V4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 1 year follow up visit |
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| Primary | V4e Area - Worse Seeing Eyes | Change (from Baseline) in visual field area using V4e stimulus size in the worse-seeing eyes. Visual field area using V4e stimulus size in the worse-seeing eyes is expressed in degree squared (minimum value 0, maximum value 20000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | degree squared | 2 years follow up visit |
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| Secondary | MS - Better Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the better-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | decibels | 1 year follow up visit |
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| Secondary | MS - Better Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the better-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | decibels | 2 years follow up visit |
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| Secondary | CMT - Better Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the better-seeing eyes. CMT was reported in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | CMT - Better Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the better-seeing eyes. CMT was reported in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| Secondary | EZ Band Horizontal - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the better-seeing eyes. EZ Band Horizontal is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | EZ Band Horizontal - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the better-seeing eyes. EZ Band Horizontal is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| Secondary | EZ Band Vertical - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the better-seeing eyes. EZ Band Vertical is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | EZ Band Vertical - Better Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the better-seeing eyes. EZ Band Vertical is reported in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| Secondary | MS - Worse Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the worse-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | decibels | 1 year follow up visit |
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| Secondary | MS - Worse Seeing Eyes | Change (from Baseline) in macular sensitivity, assessed by microperimetry, in the worse-seeing eyes. Macular sensitivity, assessed by microperimetry is expressed in decibels (minimum value 0, maximum value 30). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | decibels | 2 years follow up visit |
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| Secondary | CMT - Worse Seeing Eyes | Change (from Baseline) in Central Macular Thickness (CMT), evaluated with Optical Coherence tomography, in the worse-seeing eyes. CMT is expressed in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | CMT - Worse Seeing Eyes | Change (from Baseline) in Central Macular Thickness, evaluated with Optical Coherence tomography, in the worse-seeing eyes. CMT is expressed in micrometers (minimum value 0, maximum value 1000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| Secondary | EZ Band Horizontal - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the worse-seeing eyes. EZ Band Horizontal is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | EZ Band Horizontal - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (horizontal scan), in the worse-seeing eyes. EZ Band Horizontal is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| Secondary | EZ Band Vertical - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the worse-seeing eyes. EZ Band Vertical is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 1 year follow-up visit compared with the values at the baseline visit. | patients undergoing one-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 1 year follow up visit |
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| Secondary | EZ Band Vertical - Worse Seeing Eyes | Change (from Baseline) in Ellipsoid Zone Band Width, evaluated with Optical Coherence tomography (Vertical scan), in the worse-seeing eyes. EZ Band Vertical is expressed in micrometers (minimum value 0, maximum value 4000). The results are reported as the change in the values collected at the 2 year follow-up visit compared with the values at the baseline visit. | patients undergoing two-year follow-up visits | Posted | Mean | Standard Deviation | micrometers | 2 years follow up visit |
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| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
Not provided