Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

Alcon

Status

Completed

Conditions

Pseudophakia

Treatments

Device: Silicone IOL

Device: PMMA IOL

Device: Acrylic IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02450799

UMIN000017727 (Other Identifier)

ILQ245-P001

Details and patient eligibility

About

The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.

Enrollment

104 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
Clear intraocular media in study eye;
Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
No ocular or systemic condition which may affect visual acuity in study eye;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
Previous refractive surgery in study eye;
Previous IOL exchange in study eye;
Other protocol-specified exclusion criteria may apply.