Using the Optovue OCT to Select IOL Power

NCT01361282 | Terminated

• 1 other identifier: LEBO-2011-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Keywords

Total Corneal Power; Optical Coherence Tomography; Descemet Stripping Endothelial Keratoplasty

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• year of age or older
• Diagnosis of Fuchs' Endothelial Dystrophy with cataract
• Recent history of DSAEK with concurrent phacoemulsification \& intraocular lens (IOL) implantation

You may not qualify if:

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

Sponsors & Collaborators

• Legacy Health System: lead
• Devers Eye Institute: collaborator
• Optovue: collaborator
• Lions VisionGift Research: collaborator

Study Sites (1)

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Study Officials

• Mark A Terry, MD

  Devers Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Corneal Services

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 26, 2011
• Study Start: November 9, 2010
• Primary Completion: September 9, 2016
• Study Completion: September 9, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (1)