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

Sponsor
Innovative Medical (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01191515
Collaborator
Staar Surgical Company (Industry)
200
Enrollment
1
Location
26
Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Monofocal Intraocular Lenses

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Near and Intermediate Visual Outcomes With Monofocal Intraocular Lenses: The Mast Study
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Oct 1, 2012
Anticipated Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Vision Institute Williamsburg Virginia United States 23188

    Sponsors and Collaborators

    • Innovative Medical
    • Staar Surgical Company

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01191515
    Other Study ID Numbers:
    • The Mast Study
    First Posted:
    Aug 30, 2010
    Last Update Posted:
    Jun 14, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by , ,
    Previous Cataract patients
    Monofocal IOL implant
    Evaluation

    Study Results

    No Results Posted as of Jun 14, 2012