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| ID | Type | Description | Link |
|---|---|---|---|
| 370677 | Other Identifier | REK Norway Ethics Committee |
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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The purpose of the study is to determine if visual function is improved with implantation of a low-cylinder toric intraocular lens, relative to a non-toric intraocular lens.
The Clareon(R) T2 IOL and the Clareon (R) non-toric IOL will be randomly implanted in subjects determined to be appropriate for the T2 IOL. Visual acuity, low contrast acuity and contrast sensitivity will be measured 3 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon T2 IOL implantation | Experimental | low cylinder toric IOL |
|
| Clareon non-toric IOL implantation | Active Comparator | Non-toric IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low cylinder toric IOL | Device | Clareon T2 toric IOL implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| UDVA | Uncorrected distance visual acuty in logMAR | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Manifest Refractive Cylinder | Manifest refractive cylinder, in diopters | 3 months |
| Percentage of Eyes With <= 0.25 D of Refractive Cylinder | the percentage of eyes with <= 0.25 D of postoperative refractive cylinder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjell Gunnar Gundersen, MD, PhD | Ifocus Oyeklinikk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifocus øyeklinikk | Haugesund | 5521 | Norway |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clareon T2 IOL Implantation | Clareon T2 (low cylinder) toric IOL implanted |
| FG001 | Clareon Non-toric IOL Implantation | The Clareon aspheric (non-toric) IOL was implanted |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clareon T2 IOL Implantation | Clareon T2 (low cylinder) toric IOL implanted |
| BG001 | Clareon Non-toric IOL Implantation | The Clareon aspheric (non-toric) IOL was implanted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was considered by participant, rather than eye. |
| 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 | UDVA | Uncorrected distance visual acuty in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months | Eyes | Eyes |
|
|
From enrollment until end of follow up (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 T2 IOL Implantation | Clareon T2 (low cylinder) toric IOL implanted | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kjell Gunnar Gundersen, MD, PhD | iFocus Eye Clinic | +4752808900 | kg@ifocus.no |
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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 | Jan 19, 2022 | Apr 7, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| non-toric IOL implantation | Device | Clareon non-toric IOL |
|
|
| 3 months |
| Percentage of Eyes With <= 0.50 D of Refractive Cylinder | The percentage of eyes with <= 0.50 D of refractive cylinder | 3 months |
| Corrected Distance Visual Acuity | Corrected distance visual acuity (CDVA), logMAR | 3 months |
| Mesopic Contrast Sensitivity | Mesopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | 3 months |
| Photopic Contrast Sensitivity | Photopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | 3 months |
| Low Contrast Visual Acuity | Low contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | 3 months |
| Mean Refraction, Spherical Equivalent (MRSE) | Mean refraction, spherical equivalent (MRSE), in diopters | 3 months |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Sex was considered by participant, rather than by eye. | Sex was considered by participant, rather than eye. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Eyes |
|
|
| Secondary | Manifest Refractive Cylinder | Manifest refractive cylinder, in diopters | Posted | Mean | Standard Deviation | Dioptres | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Percentage of Eyes With <= 0.25 D of Refractive Cylinder | the percentage of eyes with <= 0.25 D of postoperative refractive cylinder | Posted | Count of Units | Eyes | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Percentage of Eyes With <= 0.50 D of Refractive Cylinder | The percentage of eyes with <= 0.50 D of refractive cylinder | Posted | Count of Units | Eyes | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Corrected Distance Visual Acuity | Corrected distance visual acuity (CDVA), logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Mesopic Contrast Sensitivity | Mesopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | Posted | Mean | Standard Deviation | log contrast sensitivity | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Photopic Contrast Sensitivity | Photopic log contrast sensitivity by spatial frequency - cycles per degree (CPD), using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | Posted | Mean | Standard Deviation | log contrast sensitivity | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Low Contrast Visual Acuity | Low contrast visual acuity (VA), logMAR, 10% contrast, using the Clinical Trial Suite (CTS) from M&S Technologies (Niles, IL, 129 USA) | Posted | Mean | Standard Deviation | logMAR | 3 months | Eyes | Eyes |
|
|
|
| Secondary | Mean Refraction, Spherical Equivalent (MRSE) | Mean refraction, spherical equivalent (MRSE), in diopters | Posted | Mean | Standard Deviation | Dioptres | 3 months | Eyes | Eyes |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Clareon Non-toric IOL Implantation | The Clareon aspheric (non-toric) IOL was implanted | 0 | 18 | 0 | 18 | 0 | 18 |
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| 3 CPD |
|
| 1.5 CPD |
|
| 6 CPD |
|
| 3 CPD |
|
| Photopic glare |
|
| Mesopic with glare |
|