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Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00343473
Enrollment
22
Registered
2006-06-23
Start date
2005-10-31
Completion date
2024-02-14
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Disorders, Fuch's Dystrophy, Prior Surgery

Keywords

Fuch's dystrophy, corneal disorders, cornea, lasik, refractive surgery

Brief summary

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.

Detailed description

The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts

Interventions

None listed

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

Female Subjects who are pregnant or breastfeeding will be included (no risks to fetus). Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. Thirty subjects from 6 different age groups (\> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; \> 60 yrs) will be recruited to determine the normal variations in anterior eye structure. LASIK patients: to participate as a LASIK patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo LASIK. Contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear. Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of \>700 microns, and/or reduced visual acuity in the morning which improves over the course of the day. Diabetic patients: for diabetic patients are specified in the posterior segment imaging section. \-

Exclusion criteria

Subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study. If participants choose they may also participate in other imaging research protocols. No risk is associated if entering multiple imaging protocols, while being a participant in this research study. \-

Design outcomes

Primary

MeasureTime frameDescription
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye2 yearsThe purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026