Trials / Completed
CompletedNCT03706066
India PanOptix Post Marketing Study
An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acrysof IQ PanOptix IOL | Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery |
| PROCEDURE | Cataract surgery | Per investigator's standard of care |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2020-01-18
- Completion
- 2020-01-18
- First posted
- 2018-10-15
- Last updated
- 2020-02-05
Locations
5 sites across 1 country: India
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03706066. Inclusion in this directory is not an endorsement.