Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

NCT00343473 | Completed DMC

• 2 other identifiers: s17-00039R01EY011289-15
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Fuch's Dystrophy; Corneal Disorders; Prior Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

  2 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

New York University School of Medicine

New York, New York, 10016, United States

Location

University of Pittsburgh UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Christopoulos V, Kagemann L, Wollstein G, Ishikawa H, Gabriele ML, Wojtkowski M, Srinivasan V, Fujimoto JG, Duker JS, Dhaliwal DK, Schuman JS. In vivo corneal high-speed, ultra high-resolution optical coherence tomography. Arch Ophthalmol. 2007 Aug;125(8):1027-35. doi: 10.1001/archopht.125.8.1027.

  PMID: 17698748 DERIVED

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Chaim Wollstein, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Ian Conner, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 23, 2006
• Study Start: October 1, 2005
• Primary Completion: September 12, 2019
• Study Completion: February 14, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

US (2)