Trial Outcomes & Findings for Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care (NCT NCT03219567)

NCT ID: NCT03219567

Last Updated: 2022-04-04

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

82 participants

Primary outcome timeframe

36 months

Results posted on

2022-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	18	64
Overall Study COMPLETED	18	63
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normals n=18 Participants 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.	Patients With a History of Cataract Surgery or High Myopia n=64 Participants 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.	Total n=82 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	73.3 years STANDARD_DEVIATION 12.7 • n=7 Participants	72.4 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	43 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	62 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	42 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	64 Participants n=7 Participants	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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.	Patients With Previous LASIK Who Will be Undergoing Cataract Surgery Patients with previous LASIK who will be undergoing cataract surgery subjects will be imaged with the OCT 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.	Patients With a History of Cataract Surgery or High Myopia n=80 eyes 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.
Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI	—	—	-0.11 mm Standard Deviation 0.35

Adverse Events

Normals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With a History of Cataract Surgery or High Myopia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Kuo, M.D.

Duke University

Phone: 919-684-3799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place