Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

Bausch & Lomb Incorporated1 site in 1 country103 target enrollmentNovember 8, 2012

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Enrollment: 103
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

V4 (6M) endpoint: primary analysis
V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

Registry

clinicaltrials.gov

Start Date

November 8, 2012

End Date

June 16, 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have clear intraocular media other than cataract in the study eye.
•Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.

Exclusion Criteria

•Subjects with ocular malformation in the study eye.
•Subjects who have had previous surgery in the study eye.
•Subjects with uncontrolled glaucoma in either eye.
•Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
•Subjects using medications known to potentially complicate cataract surgery.