AVL200 IOL for Treatment of Cataract and Presbyopia

Cataract Clinical Trial

Official title:

A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627700
• Other study ID #: CP100962
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: July 2023
• Source: Atia Vision
• Contact: Melissa Guerrero
• Phone: 408-560-3339
• Email: melissa[@]atiavision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• AVL200 IOL
The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.

Locations

Country	Name	City	State
India	Dr Agarwal's Eye Hospital	Chennai	Tamal Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Atia Vision

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in monocular distance-corrected near visual acuity	Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart	3 months postoperative