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Visual Performance With a Trifocal Intraocular Lens

Sponsor
BMI Southend Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01605058
Collaborator
(none)
30
Enrollment
1
Location
14
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity.

Patient satisfaction and quality of vision will also be assessed by way of a questionnaire.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Monocular and Binocular Unaided (UCVA) and Best Corrected Visual Acuity (BCVA) will be measured at 6m in LogMAR units under photopic conditions (85cd/m2).

    Subjective Refraction will be performed to establish any residual refractive error will for distance, intermediate and near.

    Defocus Profiles (visual acuity over imposed defocus) are measured for each patient. The patient observes the 6m LogMAR chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00D to -4.00D in 0.50D steps.. The LogMAR acuity will be recorded and the data plotted.

    Contrast Sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the Pelli-Robson Contrast Sensitivity Chart.

    Near and intermediate performance will be evaluated using the Radner Reading Charts to assess acuity (LogRAD units) and reading speed in photopic conditions 85cd/m2

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Visual Performance Adn Quality of Vision Evaluation After Implantation of a Trifocal Intraocular Lens
    Study Start Date :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2013
    Anticipated Study Completion Date :
    Aug 1, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Age 40-70yrs

      • Bilateral implantation of a trifocal intraocular lens

      Exclusion Criteria:

      • existing ocular pathology

      • surgical complications

      • corneal astigmatism > 1.50DC

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 BMI Southend Hospital Westclifff-on-Sea Essex United Kingdom SS0 9AG

      Sponsors and Collaborators

      • BMI Southend Hospital

      Investigators

      • Principal Investigator: Elizabeth M Agrippa, BSc, BMI Southend

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Elizabeth Agrippa, Optometrist, BMI Southend Hospital
      ClinicalTrials.gov Identifier:
      NCT01605058
      Other Study ID Numbers:
      • TRI 1.1
      First Posted:
      May 24, 2012
      Last Update Posted:
      May 30, 2012
      Last Verified:
      May 1, 2012
      Additional relevant MeSH terms:
      Cataract

      Study Results

      No Results Posted as of May 30, 2012