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

Duke University

Status: Terminated

Conditions: Image, Body

Treatments: Device: Magnetic resonance imaging (MRI); Device: Optical Coherence Tomography (OCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03219567

Pro00056946

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Normals

Experimental group

Description:

Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.

Treatment:

Device: Optical Coherence Tomography (OCT)

Patients with a history of cataract surgery or high myopia

Experimental group

Description:

Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.

Treatment:

Device: Optical Coherence Tomography (OCT)

Device: Magnetic resonance imaging (MRI)