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A Clinical Study to check the safety and effectiveness of AVL200 Modular Intraocular Lens.

A Prospective, Open-Label, Single-Center Study of the Safety and Effectiveness of the AVL200 Modular Intraocular Lens System.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052664
Enrollment
30
Registered
2023-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H258- Other age-related cataract

Interventions

Intervention1: AVL200 Modular IOL System.: The AVL200 consists of a fluid-filled shell (Base) and a monofocal spherical biconvex disk (Lens).The Lens is docked into the Base to create a Lens System. T

Sponsors

ATIA VISION,INC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Visually significant cataract. 2)Best corrected distance visual acuity between 20/40 and 20/200. 3)Corneal astigmatism 4)Potential distance visual acuity of 20/25 or better.

Exclusion criteria

Exclusion criteria: 1)Uncontrolled systemic disease that could increase operative risk or confound outcome. 2)Use of medication that could affect accommodation. 3)Previous corneal surgery or significant corneal abnormalities. 3)Ocular pathology or degenerative disorder having potential to impair visual acuity. 4)Pupil abnormality. 5)Intraoperative cataract surgery complications that could affect IOL implantation or positioning.

Design outcomes

Primary

MeasureTime frame
1)Uncorrected distance visual acuity (UCDVA) â?? monocular and binocular. 2)Uncorrected intermediate visual acuity (UCIVA) â?? monocular and binocular. 3) Uncorrected distance visual acuity (UCDVA) â?? monocular and binocular. 4)Distance-corrected intermediate visual acuity (DCIVA) â?? monocular and binocular. 5)Distance-corrected near visual acuity (DCNVA) â?? monocular and binocular.Timepoint: Post-Operation Month 1,3,6,12 and 36.—

Secondary

MeasureTime frame
1)Ocular adverse events (AE) 2)Secondary surgical interventions related to design characteristics of the AVL200 IOL System 3)Best-corrected distance visual acuity (BCDVA) â?? monocular and binocular 4)Far contrast sensitivity (mesopic, with and without glare) 5)Intraocular pressure (IOP) 6)Endothelial cell density (ECD) Timepoint: Throughout the study, i.e., Post Op Day 1, Week 1, Month 1, 3, 6 and 12.—

Countries

India

Contacts

Public ContactMukul Maurya

Dr. Agarwals Eye Hospital

agarwal_ashvin@dragarwal.com9840430100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026