Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care

Stopped early

Conditions studied: Image, Body

In brief

The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT). The research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison. There are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.

Key facts

Study ID

NCT03219567

Run by

Duke University

People needed

82

Starts

2014-10-09

Expected to finish

2019-11-21

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21 years or older.
• Pseudophakic group: has had prior uncomplicated cataract surgery with a monofocal or toric intraocular lens, able to undergo head MRI
• High myopia group: refraction equal to or stronger than -6 D spherical equivalent, able to undergo head MRI

You may not qualify if…

• under 21 years of age, unable or unwilling to give consent.
• Pseudophakic group: complications with cataract surgery or insertion of a multifocal intraocular lens, failure to pass MRI pre-screening (e.g. prior metallic implants, claustrophobic), unable to fixate.
• High myopia group: failure to pass MRI pre-screening, unable to fixate.

Where it is running

• Duke University Duke Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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