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

NCT03219567 | Terminated Results

• 1 other identifier: Pro00056946
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI

  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.

  36 months

Study Arms (2)

Normals

EXPERIMENTAL

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

Device: Optical Coherence Tomography (OCT)

Patients with a history of cataract surgery or high myopia

EXPERIMENTAL

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

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

Interventions

Optical Coherence Tomography (OCT) 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.

Normals; Patients with a history of cataract surgery or high myopia

Magnetic resonance imaging (MRI) 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.

Patients with a history of cataract surgery or high myopia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Anthony Kuo, M.D.
• Organization: Duke University

anthony.kuo@duke.edu

919-684-3799

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: October 9, 2014
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: April 4, 2022
• Results First Posted: April 4, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)