India PanOptix Post Marketing Study
An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
2 other identifiers
observational
80
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2020
CompletedFebruary 5, 2020
February 1, 2020
1 year
October 11, 2018
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
PanOptix
Cataract surgery with implantation of Acrysof IQ PanOptix IOL
Interventions
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery
Eligibility Criteria
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.
You may qualify if:
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
- Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.
You may not qualify if:
- Pregnant or lactating, current or planned, during the course of the study;
- Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
- Clinically significant corneal abnormalities;
- History of retinal conditions;
- Previous refractive surgery, including LASIK;
- Glaucoma;
- Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (5)
Alcon Investigative Site
Ahmedabad, Gujarat, 380052, India
Alcon Investigative Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Alcon Laboratories (India) PVT.LTD
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 15, 2018
Study Start
January 15, 2019
Primary Completion
January 18, 2020
Study Completion
January 18, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share