AVL200 IOL for Treatment of Cataract and Presbyopia

Sponsor
Atia Vision (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05627700
Collaborator
(none)
60
1
1
16.2
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AVL200 IOL
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Improvement in monocular best corrected distance visual acuity [Baseline, 3 months postoperative]

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

Secondary Outcome Measures

  1. Improvement in monocular distance-corrected near visual acuity [Baseline, 3 months postoperative]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr Agarwal's Eye Hospital Chennai Tamal Nadu India 600018

Sponsors and Collaborators

  • Atia Vision

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Atia Vision
ClinicalTrials.gov Identifier:
NCT05627700
Other Study ID Numbers:
  • CP100962
First Posted:
Nov 28, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2022