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

November 12, 2019 updated by: Bausch & Lomb Incorporated

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Labege, France, 31670
        • Bausch & Lomb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IOL implantation
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 6 months
Corrected distance visual acuity (CDVA)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incision size
Time Frame: 6 Months
Incision size before and after implantation
6 Months
Refraction
Time Frame: 6 Months
Manifest refraction spherical equivalent. Accuracy to target refraction
6 Months
Visual Acuity
Time Frame: 6 Months
Uncorrected distance visual acuity (UDVA)
6 Months
EPCO
Time Frame: 24 Months
3 mm evaluation of posterior capsule opacification (EPCO) score
24 Months
Lens decentration
Time Frame: 6 Months
6 Months
Laser capsulotomy
Time Frame: 24 Months
Removal of post-surgical, posterior capsular opacification (PCO)
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2012

Primary Completion (ACTUAL)

June 16, 2015

Study Completion (ACTUAL)

June 16, 2015

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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