AVL200 IOL for Treatment of Cataract and Presbyopia

July 26, 2023 updated by: Atia Vision

A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Tamal Nadu
      • Chennai, Tamal Nadu, India, 600018
        • Recruiting
        • Dr Agarwal's Eye Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: 044 4300 8800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVL200 IOL
The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points
Device: AVL200 IOL
The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atia Vision

Investigators

  • Principal Investigator: Ashvin Agarwal, MD, Dr. Agarwals Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP100962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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