Using the Optovue OCT to Select IOL Power

NCT ID: NCT01361282

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-09

Study Completion Date

2016-09-09

Brief Summary

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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.

Detailed Description

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Conditions

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Fuchs' Endothelial Dystrophy Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Devers Eye Institute

OTHER

Sponsor Role collaborator

Optovue

INDUSTRY

Sponsor Role collaborator

Lions VisionGift Research

OTHER

Sponsor Role collaborator

Legacy Health System

OTHER

Sponsor Role lead

Responsible Party

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Mark A Terry

Director of Corneal Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark A Terry, MD

Role: PRINCIPAL_INVESTIGATOR

Devers Eye Institute

Locations

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Devers Eye Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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LEBO-2011-1

Identifier Type: -

Identifier Source: org_study_id

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