Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study

June 13, 2012 updated by: Innovative Medical
The purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal IOL ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • United States
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • Advanced Vision Institute
        • Principal Investigator:
          • Glenn Campbell, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective evaluation of 200 patients male or female at least 18 years of age who have previously undergone phacoemulsification (the break-up and removal of a cataract) between one and 36 months earlier

Description

Inclusion Criteria:

  • Male or female patients at least 18 years of age
  • Patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months
  • At least 1 month postop before follow-up evaluation
  • All Patients must have a DCVA of 20/25 or better

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Near visual outcomes with Monofocal IOL
Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye.
Device: Monofocal Intraocular Lenses
Monofocal Intraocular Lenses
Intermediate Visual outcomes
Evaluation of intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOl placement in the capsular bag in at least one eye.
Device: Monofocal Intraocular Lenses
Monofocal Intraocular Lenses

Collaborators and Investigators

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

Sponsor

Innovative Medical

Collaborators

Staar Surgical Company

Investigators

  • Principal Investigator: Glenn Campbell, MD, Advanced Vision Institute

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

August 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • The Mast Study

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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