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NCT01361282 · ClinicalTrials.gov registry record

Using the Optovue OCT to Select IOL Power

A clinical trial, sponsored by Legacy Health System.

Terminated
Registry status
50
Enrollment target

NCT01361282: Clinical Trial study, sponsored by Legacy Health System.

NCT01361282 is a clinical trial that was terminated before completion, run by Legacy Health System. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01361282 was terminated before completion, sponsored by Legacy Health System.

TERMINATED
Registry status
50 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2010-11-09
Est. Completion 2016-09-09
Legacy Health System

21 total trials

Why NCT01361282 stopped before completion

NCT01361282 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01361282 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01361282 about?

NCT01361282 is a clinical study titled "Using the Optovue OCT to Select IOL Power". 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 ...

What is the current status of trial NCT01361282?

This trial is currently terminated. The enrollment target is 50 participants. The study started on 2010-11-09. Estimated completion is 2016-09-09.

Who is sponsoring clinical trial NCT01361282?

This trial is sponsored by Legacy Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01361282, the US trial registry maintained by the National Library of Medicine. NCT01361282 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.