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Using the Optovue OCT to Select IOL Power

Sponsor
Legacy Health System (Other)
Overall Status
Terminated
CT.gov ID
NCT01361282
Collaborator
Devers Eye Institute (Other), Optovue (Industry), Lions VisionGift Research (Other)
50
Enrollment
1
Location
70
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many patients with endothelial dysfunction also present with cataracts. It is therefore common practice to perform cataract extraction and intraocular lens (IOL) implantation during the same operation and immediately prior to Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), in order to minimize trips to the operating room and the associated risks of ocular surgery. However, the unique posterior corneal anatomy of the DSAEK recipient makes it difficult to predict pre-operatively the proper power of IOL to place, and some patients end up with a mismatched lens that requires spectacle correction. The current gold standard for IOL power calculation (A-Scan optical biometry) takes measurements of the anterior surface of the cornea and makes assumptions about the posterior surface that are violated by the unique hourglass shape of the donor DSAEK graft. New optical coherence tomography (OCT) technology provides us with the ability to measure curvature in both the anterior and posterior aspects of the cornea in order to generate an IOL calculation that has the potential to give more accurate results for our DSAEK patients.

The investigators will be using the Optovue to perform corneal power analysis on patients who have already received DSAEK and cataract surgery, in order to compare the post-op Optovue power calculations to the pre-operative power calculations provided by the A-Scan. If the OCT is shown to provide accurate IOL power calculations, then some patients might be better served by a two-stage procedure where DSAEK is performed and then followed six months later by cataract surgery using the OCT to calculate IOL power.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Total Corneal Power Calculations for Intraocular Lens Selection Using the Optovue OCT in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) Patients
    Actual Study Start Date :
    Nov 9, 2010
    Actual Primary Completion Date :
    Sep 9, 2016
    Actual Study Completion Date :
    Sep 9, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Triple Procedure

    All qualifying patients will have received DSAEK with concurrent cataract extraction and intraocular lens placement. Data collection will occur between 6-18 months post-operation.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • 18 year of age or older

      • Diagnosis of Fuchs' Endothelial Dystrophy with cataract

      • Recent history of DSAEK with concurrent phacoemulsification & intraocular lens (IOL) implantation

      Exclusion Criteria:
      • Diagnosis of ocular comorbidity that might be limiting to visual acuity (glaucoma, retinal disease, surface irregularities, etc.)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Devers Eye Institute Portland Oregon United States 97210

      Sponsors and Collaborators

      • Legacy Health System
      • Devers Eye Institute
      • Optovue
      • Lions VisionGift Research

      Investigators

      • Principal Investigator: Mark A Terry, MD, Devers Eye Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Mark A Terry, Director of Corneal Services, Legacy Health System
      ClinicalTrials.gov Identifier:
      NCT01361282
      Other Study ID Numbers:
      • LEBO-2011-1
      First Posted:
      May 26, 2011
      Last Update Posted:
      Mar 13, 2017
      Last Verified:
      Mar 1, 2017
      Keywords provided by Mark A Terry, Director of Corneal Services, Legacy Health System
      Total Corneal Power
      Optical Coherence Tomography
      Descemet Stripping Endothelial Keratoplasty
      Additional relevant MeSH terms:
      Cataract
      Fuchs' Endothelial Dystrophy

      Study Results

      No Results Posted as of Mar 13, 2017