AVL200 IOL for Treatment of Cataract and Presbyopia

Atia Vision

Status: Active, not recruiting

Conditions: Cataract

Treatments: Device: AVL200 IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05627700

CP100962

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

AVL200 IOL

Experimental group

Description:

The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points

Treatment:

Device: AVL200 IOL