Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-02-19 @ 5:27 AM
Study NCT ID:
NCT03706066
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
India PanOptix Post Marketing Study
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTRI/2018/11/016467 | OTHER | CTRI | View |