Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The specific aims of the clinical studies are to: * Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion. * Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection. * Simulate visual field results by combining structural and angiography OCT data. * Assess abilities of above technologies and OCT-derived parameters on predicting glaucoma detection, conversion, and progression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• No history or evidence of retinal pathology or glaucoma

• Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).

• Intraocular pressure \< 21 mm Hg

• Central corneal pachymetry \> 500 microns

• No chronic ocular or systemic corticosteroid use

• Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)

• Normal appearing ONH and NFL: vertical and horizontal cup/disc ratio (CDR) ≤ 0.5 and intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect

• Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions

• ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:

‣ diffuse or localized thinning of the rim

⁃ disc (splinter) hemorrhage

⁃ notch in the rim

⁃ vertical cup/disc ratio greater than the fellow eye by \> 0.2

• Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.

Locations
United States
Oregon
Oregon Health & Science University, Casey Eye Institute
RECRUITING
Portland
Contact Information
Primary
Chinmay Deshpande, M.Optom.
deshpanc@ohsu.edu
503-494-9628
Backup
Denzil Romfh, OD
romfhd@ohsu.edu
503-494-4351
Time Frame
Start Date: 2013-09-25
Estimated Completion Date: 2026-05
Participants
Target number of participants: 160
Treatments
Glaucoma Group
Patients with clinically confirmed glaucomatous ONH or NFL defects, with or without VF abnormalities
Normal Group
Volunteers with healthy eyes
Related Therapeutic Areas
Sponsors
Collaborators: National Eye Institute (NEI)
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov