Overview

This trial is active, not recruiting.

Condition cataract
Treatments iol implantation
Phase phase 4
Sponsor Bausch & Lomb Incorporated
Start date November 2012
End date October 2014
Trial size 103 participants
Trial identifier NCT01615861, 714

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
iol implantation
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
iol implantation
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.

Primary Outcomes

Measure
Visual Acuity
time frame: 6 months

Secondary Outcomes

Measure
Incision size
time frame: 6 Months
Refraction
time frame: 6 Months
Visual Acuity
time frame: 6 Months
EPCO
time frame: 24 Months
Lens decentration
time frame: 6 Months
Laser capsulotomy
time frame: 24 Months

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Bausch & Lomb Incorporated.