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

" Visual Outcomes Following Implantation Of A Wave Front Shaping IOL In Patients With Early Age-related Macular Degeneration: A Prospective, interventional Case Series Studyâ??

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047565
Enrollment
40
Registered
2022-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H250- Age-related incipient cataract

Interventions

Intervention1: Cataract Surgery with vivity IOL implantation: SINGLE SURGICAL INTERVENTION Control Intervention1: Target refraction mini monovision: Cataract Surgery with vivity IOL implantation

Sponsors

Alcon Laboratiores USA
Lead Sponsor

Eligibility

Inclusion criteria

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 -

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Unaided and corrected distance visual acuity (LogMAR) at 4 metres on the ETDRS chartTimepoint: 3 months

Secondary

MeasureTime frame
Unaided and corrected distance visual acuity (LogMAR) at 4 metres on the ETDRS chartTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Abhay R Vasavada

Raghudeep Eye Hospital

icirc@abhayvasavada.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026