Using the Optovue OCT to Select IOL Power

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Devers Eye Institute
Optovue, Inc.
Lions VisionGift Research
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT01361282
First received: May 25, 2011
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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
Fuchs' Endothelial Dystrophy
Cataract

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Estimated Enrollment: 54
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All study subjects will have received Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for Fuchs' Endothelial Dystrophy, together with concurrent cataract surgery. Data collection will occur between 6 and 18 months following surgery.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361282

Locations
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Devers Eye Institute
Optovue, Inc.
Lions VisionGift Research
Investigators
Principal Investigator: Mark A Terry, MD Devers Eye Institute
  More Information

No publications provided

Responsible Party: Mark A. Terry, MD, Legacy Health System
ClinicalTrials.gov Identifier: NCT01361282     History of Changes
Other Study ID Numbers: LEBO-2011-1
Study First Received: May 25, 2011
Last Updated: May 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
Total Corneal Power
Optical Coherence Tomography
Descemet Stripping Endothelial Keratoplasty

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Cataract
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Lens Diseases

ClinicalTrials.gov processed this record on July 29, 2014