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OpenTrials
Completed

NCT Number: NCT05627700

AVL200 IOL for Treatment of Cataract and Presbyopia

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Agarwal's Eye Hospital

Chennai, Tamal Nadu, 600018, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVL200 IOL

Device

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

Primary outcomes

  1. Change in monocular best corrected distance visual acuity

    Time frame: 3 months postoperative

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

Secondary outcomes

  1. Change in monocular distance-corrected near visual acuity

    Time frame: 3 months postoperative

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Atia Vision

Industry

Registry information

Official study title

A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 28, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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