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Using the Optovue OCT to Select IOL Power

This study has been terminated.
(The DSAEK procedure was discontinued as the standard of care for the intended cohort.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361282
First Posted: May 26, 2011
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Legacy Devers Eye Institute
Optovue
Lions VisionGift Research
Information provided by (Responsible Party):
Mark A Terry, Legacy Health System
May 25, 2011
May 26, 2011
March 13, 2017
November 9, 2010
September 9, 2016   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01361282 on ClinicalTrials.gov Archive Site
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Using the Optovue OCT to Select IOL Power
Evaluation of Total Corneal Power Calculations for Intraocular Lens Selection Using the Optovue OCT in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) Patients

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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample
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.
  • Fuchs' Endothelial Dystrophy
  • Cataract
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
September 9, 2016
September 9, 2016   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01361282
LEBO-2011-1
No
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Mark A Terry, Legacy Health System
Legacy Health System
  • Legacy Devers Eye Institute
  • Optovue
  • Lions VisionGift Research
Principal Investigator: Mark A Terry, MD Legacy Devers Eye Institute
Legacy Health System
March 2017