AVL200 IOL for Treatment of Cataract and Presbyopia

Atia Vision9 enrolled

Overview

This study is to evaluate the performance of the AVL200 IOL in terms of visual function improvement over a range of focal points. Participants meeting eligibility criteria will undergo cataract surgery with implantation of the AVL200 intraocular lens (IOL), then be followed through 1 year postoperatively. Postoperative assessments include safety and visual function.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

AVL200 IOLDEVICE

The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Visually significant cataract * Best corrected distance visual acuity between 20/40 and 20/200 * Potential distance visual acuity of 20/32 or better * Corneal astigmatism ≤ 1.5 diopters Exclusion Criteria: * Use of medication that could affect accommodation * Previous corneal surgery or significant corneal abnormalities * Ocular pathology or degenerative disorder having potential to impair visual acuity * Pupil abnormality * Intraoperative cataract surgery complications that could affect IOL implantation or positioning

Locations (1)

Dr Agarwal's Eye Hospital

Chennai, Tamal Nadu, India

Outcomes

Primary Outcomes

Change in monocular best corrected distance visual acuity

Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart

Time frame: 3 months postoperative

Secondary Outcomes

Change in monocular distance-corrected near visual acuity

Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart

Time frame: 3 months postoperative

Data from ClinicalTrials.gov

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