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

Study Overview
=================
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.

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

Conditions
-----------------
Image, Body

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography (OCT)
* Device: Magnetic resonance imaging (MRI)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normals<br>Normal subjects will be imaged with the OCT system to ensure the imaging range of the system. | Device: Optical Coherence Tomography (OCT)<br>* 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.<br>|
| Experimental: Patients with a history of cataract surgery or high myopia<br>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)<br>* 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.<br>Device: Magnetic resonance imaging (MRI)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |