Clinical trial NCT03706066: India PanOptix Post Marketing Study
Official title: An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation
timeFrame: Month 3 (following second eye surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Alcon Investigative Site
state: Gujarat
city: Chennai
country: India
facility: Alcon Investigative Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Alcon Investigative Site
state: Tamilnadu
city: Bangalore
country: India
facility: Alcon Investigative Site
city: Hyderabad
country: India
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Laboratories (India) PVT.LTD
name: Study Director
role: STUDY_DIRECTOR
References: