India PanOptix Post Marketing Study

Cataract Clinical Trial

Official title:

An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706066
• Other study ID #: ILD432-P001
• Secondary ID: CTRI/2018/11/016
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: January 18, 2020

Study information

• Verified date: February 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
India	Alcon Investigative Site	Ahmedabad	Gujarat
India	Alcon Investigative Site	Bangalore
India	Alcon Investigative Site	Chennai	Tamil Nadu
India	Alcon Investigative Site	Coimbatore	Tamilnadu
India	Alcon Investigative Site	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)