Cataract
Conditions
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.
Interventions
DEVICEAcrysof IQ PanOptix IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery
PROCEDURECataract surgery
Per investigator's standard of care
Sponsors
Alcon Research
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation | Month 3 (following second eye surgery) | Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR). |
Countries
India
Outcome results
None listed