Image, Body
Conditions
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.
Interventions
DEVICEOptical 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.
DEVICEMagnetic 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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normals Normal subjects will be imaged with the OCT system to ensure the imaging range of the system.
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. | 18 |
| 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.
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.
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. | 64 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Normals | Total | Patients With a History of Cataract Surgery or High Myopia |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 12.1 | 72.4 years STANDARD_DEVIATION 12.7 | 73.3 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 78 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 15 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 58 Participants | 42 Participants |
| Region of Enrollment United States | 18 Participants | 82 Participants | 64 Participants |
| Sex: Female, Male Female | 12 Participants | 33 Participants | 21 Participants |
| Sex: Female, Male Male | 6 Participants | 49 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 64 |
| other Total, other adverse events | 0 / 18 | 0 / 64 |
| serious Total, serious adverse events | 0 / 18 | 0 / 64 |
Outcome results
Primary
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.
Time frame: 36 months
Population: Participants who were imaged with both the OCT system and MRI (Patients with a history of cataract surgery or high myopia group only). Data not collected on 40 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With a History of Cataract Surgery or High Myopia | Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI | -0.11 mm | Standard Deviation 0.35 |
Comparison: OCT compared to MRIp-value: 0.35t-test, 2 sided