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Using the Optovue OCT to Select IOL Power

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ClinicalTrials.gov Identifier: NCT01361282
Recruitment Status : Terminated (The DSAEK procedure was discontinued as the standard of care for the intended cohort.)
First Posted : May 26, 2011
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):

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
Fuchs' Endothelial Dystrophy Cataract

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 : November 9, 2010
Primary Completion Date : September 9, 2016
Study Completion Date : September 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Groups and 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.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361282

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

Responsible Party: Mark A Terry, Director of Corneal Services, Legacy Health System
ClinicalTrials.gov Identifier: NCT01361282     History of Changes
Other Study ID Numbers: LEBO-2011-1
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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

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