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Visual Outcomes following implantation of a extended vision IOL in patients with early macular degeneratio

Phase 4
Conditions
Health Condition 1: H250- Age-related incipient cataract
Registration Number
CTRI/2022/11/047565
Lead Sponsor
Alcon Laboratiores USA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients with uncomplicated, age related cataracts and nuclear sclerosis ranging from grade I to IV on the LOCS III grading system and pre-existing stable, early dry age-related macular degeneration. Early dry AMD will be defined based on the AREDS 2 study criteria (i.e. Multiple small drusen <63 microns or few intermediate drusen >63 - <125 microns, or pigmentary changes at macula). Only one eye of each patient will be included.

Exclusion Criteria

Choroidal neovascularization, severe dry AMD, large drusen, foveal thickness >300 microns on optical coherence tomography (OCT), macular hole on OCT, prior history of intravitreal injection / implant, other ocular comorbidities including but not limited to glaucoma, uveitis, pseudoexfoliation syndrome, zonular weakness, macular pathology, diabetic retinopathy, ocular coloboma etc. nonreactive or irregular pupil, prior ocular surgery or trauma.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
naided and corrected distance visual acuity (LogMAR) at <br/ ><br>4 metres on the ETDRS chartTimepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
naided and corrected distance visual acuity (LogMAR) at <br/ ><br>4 metres on the ETDRS chartTimepoint: 3 months
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