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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Monofocal |
| ||
| Light-Adjustable Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Monofocal | Device | Clareon Monofocal Intraocular Lens (toric and non-toric) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Corrected Distance Visual Acuity (CDVA) | 3 months postop |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity (UDVA) | 3 months postop | |
| Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 3 months postop | |
| Binocular Uncorrected Intermediate Visual Acuity (UIVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance-corrected Near Visual Acuity (DCNVA) | 3 months postop | |
| Binocular Uncorrected Near Visual Acuity (UNVA) | 3 months postop | |
| Monocular Distance Corrected Defocus Curve |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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Eligible participants will be adult normal astigmatic (≥ 0.75D corneal astigmatism) cataract patients presenting for cataract surgery who are considered appropriate candidates for intraocular lens implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Clayton G Blehm, MD | Gainesville Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Eye Associates | Gainesville | Georgia | 30501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clareon Monofocal | Bilateral Implantation of the Clareon Monofocal IOL |
| FG001 | Light-Adjustable Lens | Bilateral Implantation of the Light-Adjustable Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clareon Monofocal | Bilateral Implantation of the Clareon Monofocal IOL |
| BG001 | Light-Adjustable Lens | Bilateral Implantation of the Light-Adjustable Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Binocular Corrected Distance Visual Acuity (CDVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
3 months
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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 | Clareon Monofocal | Clareon Monofocal: Clareon Monofocal Intraocular Lens (toric and non-toric) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| YAG laser capsulotomy | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm | North Georgia Eye Associates | 770-532-4444 | claytonblehm@gmail.com |
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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 | Oct 20, 2023 | Nov 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Light-Adjustable Lens |
| Device |
Light-Adjustable Lens (Intraocular Lens) |
|
| 3 months postop |
| Monocular Corrected Distance Visual Acuity (CDVA) | 3 months postop |
| Monocular Uncorrected Distance Visual Acuity (UDVA) | 3 months postop |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 3 months postop |
| Monocular Uncorrected Intermediate Visual Acuity (UIVA) | 3 months postop |
| 3 months postop |
| Binocular Distance Corrected Defocus Curve | 3 months postop |
| Manifest Refraction | MRSE, residual sphere, and residual astigmatism | 3 months postop |
| Patient Reported Spectacle Usage Questionnaire (PRSIQ) | Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision. | 3 months postop |
| Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations) | Aberrometry was performed using the iTrace (Tracy Technologies, USA) | 3 months postop |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Binocular Uncorrected Distance Visual Acuity (UDVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Secondary | Binocular Uncorrected Intermediate Visual Acuity (UIVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Secondary | Monocular Corrected Distance Visual Acuity (CDVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop | eyes | eyes |
|
|
|
| Secondary | Monocular Uncorrected Distance Visual Acuity (UDVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop | eyes | eyes |
|
|
|
| Secondary | Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop | eyes | eyes |
|
|
|
| Secondary | Monocular Uncorrected Intermediate Visual Acuity (UIVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop | eyes | eyes |
|
|
|
| Other Pre-specified | Binocular Distance-corrected Near Visual Acuity (DCNVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Other Pre-specified | Binocular Uncorrected Near Visual Acuity (UNVA) | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Other Pre-specified | Monocular Distance Corrected Defocus Curve | Data were collected for Dominant and Non-Dominant Eyes for the LAL Group and Dominant Eyes for the Clareon Group | Posted | Mean | Standard Deviation | logMAR | 3 months postop | eyes | eyes |
|
|
|
| Other Pre-specified | Binocular Distance Corrected Defocus Curve | Posted | Mean | Standard Deviation | logMAR | 3 months postop |
|
|
|
| Other Pre-specified | Manifest Refraction | MRSE, residual sphere, and residual astigmatism | Posted | Mean | Standard Deviation | D | 3 months postop | eyes | eyes |
|
|
|
| Other Pre-specified | Patient Reported Spectacle Usage Questionnaire (PRSIQ) | Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision. | Count of participants answering "None of the time" when asked "During the last 7 days, how often did you need glasses or contacts" | Posted | Number | percentage of participants | 3 months postop |
|
|
|
| Other Pre-specified | Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations) | Aberrometry was performed using the iTrace (Tracy Technologies, USA) | 70 dominant and 70 non-dominant eyes (140 eyes total) in the Clareon Group 68 dominant and 68 non-dominant eyes (136 eyes total) in the LAL Group | Posted | Mean | Standard Deviation | microns | 3 months postop | eyes | eyes |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 6 |
| 70 |
| EG001 | Light-Adjustable Lens | Light-Adjustable Lens: Light-Adjustable Lens (Intraocular Lens) | 0 | 68 | 0 | 68 | 14 | 68 |
| Dry Eye | Eye disorders | Non-systematic Assessment |
|
| Herpes simplex virus keratitis | Eye disorders | Non-systematic Assessment |
|
| Endophthalmitis | Eye disorders | Non-systematic Assessment |
|
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|
| 1.00 D (Non-Dominant Eyes) |
|
|
| 0.50 D (Dominant Eyes) |
|
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| 0.50 D (Non-Dominant Eyes) |
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| 0.25 D (Dominant Eyes) |
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| 0.25 D (Non-Dominant Eyes) |
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| 0.00 D (Dominant Eyes) |
|
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| 0.00 D (Non-Dominant Eyes) |
|
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| -0.25 D (Dominant Eyes) |
|
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| -0.25 D (Non-Dominant Eyes) |
|
|
| -0.50 D (Dominant Eyes) |
|
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| -0.50 D (Non-Dominant Eyes) |
|
|
| -1.00 D (Dominant Eyes) |
|
|
| -1.00 D (Non-Dominant Eyes) |
|
|
| -1.50 D (Dominant Eyes) |
|
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| -1.50 D (Non-Dominant Eyes) |
|
|
| -2.00 D (Dominant Eyes) |
|
|
| -2.00 D (Non-Dominant Eyes) |
|
|
| -2.50 D (Dominant Eyes) |
|
|
| -2.50 D (Non-Dominant Eyes) |
|
|
| 0.25 D |
|
| 0.00 D |
|
| -0.25 D |
|
| -0.50 D |
|
| -1.00 D |
|
| -1.50 D |
|
| -2.00 D |
|
| -2.50 D |
|
| Cylinder (Dominant Eyes) |
|
| Cylinder (Non-Dominant Eyes) |
|
| MRSE (Dominant Eyes) |
|
| MRSE (Non-Dominant Eyes) |
|
| Near |
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| Overall |
|
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| Ocular HOA (Non-Dominant Eyes) |
|
|
| Internal HOA (Dominant Eyes) |
|
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| Internal HOA (Non-Dominant Eyes) |
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| Corneal HOA (Dominant Eyes) |
|
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| Corneal HOA (Non-Dominant Eyes) |
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