NCT05627700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

November 16, 2022

Last Update Submit

February 18, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months postoperative

Secondary Outcomes (1)

  • Change in monocular distance-corrected near visual acuity

    3 months postoperative

Study Arms (1)

AVL200 IOL

EXPERIMENTAL

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

Interventions

AVL200 IOLDEVICE

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

AVL200 IOL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Agarwal's Eye Hospital

Chennai, Tamal Nadu, 600018, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Ashvin Agarwal, MD

    Dr. Agarwals Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

July 25, 2022

Primary Completion

December 30, 2025

Study Completion

February 10, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)