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

NCT ID: NCT03219567

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-09
• Study Completion Date: 2019-11-21

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.

Conditions

Image, Body

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normals

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

Group Type: EXPERIMENTAL

Optical Coherence Tomography (OCT)

Intervention Type: DEVICE

Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.

The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.

Patients with a history of cataract surgery or high myopia

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

Group Type: EXPERIMENTAL

Optical Coherence Tomography (OCT)

Intervention Type: DEVICE

Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.

The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.

Magnetic resonance imaging (MRI)

Intervention Type: DEVICE

Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.

Interventions

Optical Coherence Tomography (OCT)

Optical coherence tomography (OCT) is a non-contact, micrometer scale imaging technique, it provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D.

The study team will develop the hardware systems and software algorithms necessary to enable simultaneous OCT imaging of all the refractive surfaces of the eye.

Intervention Type: DEVICE

Magnetic resonance imaging (MRI)

Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Duke Eye Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00056946

Identifier Type: -

Identifier Source: org_study_id