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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2018/11/016467 | Other Identifier | CTRI |
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The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.
The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix | Cataract surgery with implantation of Acrysof IQ PanOptix IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acrysof IQ PanOptix IOL | Device | Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation | Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR). | Month 3 (following second eye surgery) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specified inclusion and/or exclusion criteria may apply.
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This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Alcon Laboratories (India) PVT.LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Ahmedabad | Gujarat | 380052 | India | ||
| Alcon Investigative Site |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Cataract surgery | Procedure | Per investigator's standard of care |
|
| Chennai |
| Tamil Nadu |
| 600006 |
| India |
| Alcon Investigative Site | Coimbatore | Tamil Nadu | 641002 | India |
| Alcon Investigative Site | Bangalore | 560010 | India |
| Alcon Investigative Site | Hyderabad | 500034 | India |