AVL200 IOL for Treatment of Cataract and Presbyopia

NCT ID: NCT05627700

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

AVL200 IOL

Intervention Type DEVICE

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

Interventions

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AVL200 IOL

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atia Vision

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashvin Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Agarwals Eye Hospital

Locations

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Dr Agarwal's Eye Hospital

Chennai, Tamal Nadu, India

Site Status

Countries

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India

Other Identifiers

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CP100962

Identifier Type: -

Identifier Source: org_study_id

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