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

Terminated

• Conditions: Image, Body
• Interventions: Device: Optical Coherence Tomography (OCT); Device: Magnetic resonance imaging (MRI)

• Registration Number: NCT03219567
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-09
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Primary Completion: 2019-11-21
• Study Completion: 2019-11-21
• Disposition First Submitted: 2020-11-16
• Disposition First Submitted QC: 2020-11-20
• Status Verified: 2021-11
• Results First Submitted: 2021-11-22
• Results First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-11
• Results First Posted: 2022-04-04
• Disposition First Posted: 2022-04-04
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normals	Optical Coherence Tomography (OCT)	Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.
Patients with a history of cataract surgery or high myopia	Optical Coherence Tomography (OCT)	Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.
Patients with a history of cataract surgery or high myopia	Magnetic resonance imaging (MRI)	Subjects will be imaged with both the OCT system and MRI. Reconstructions of the eye from each modality will then be compared.

Primary Outcome Measures

Name	Time	Method
Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI	36 months	The radius of curvature of the posterior eye will be measured via surface fitting of the posterior eye data from OCT and MRI. Data reported reflects the Rc of the posterior eye measured by OCT minus the value obtained by MRI measurement.

Trial Locations

Locations (1)

Duke University Duke Eye Center; 🇺🇸 Durham, North Carolina, United States