Functional and Structural Imaging for Glaucoma

ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorOregon Health and Science University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Best-corrected visual acuity less than 20/40

Age < 40 or >85 years

Refractive error of > +3.00 D or < -7.00 D

Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation

Trial population

The study will enroll both males and females and include all ethnic and racial groups through clinical practices in the centers. The study will enroll subjects in the older adult age range commonly affected by glaucoma - 40 years or older. The study will exclude people with life-threatening or debilitating illness that would make 5-year participation unlikely or cooperation with tests difficult. For similar reasons those older than 85 years are excluded. The study also excludes those with any disease that might confound the diagnosis of glaucoma. Otherwise people with any health status are eligible for enrollment. Two groups of participants are recruited in the study: healthy controls or participants with confirmed glaucoma.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

249 Participants
are grouped into 2 trial groups
Group A: Glaucoma Group
Group B: Normal Group

Trial outcomes

Primary outcomes

1

Measure of retinal non-perfusion areas in mm2

Time frame
5 years
2

Measure vessel density in percentage (%)

Time frame
5 years
3

Determine accuracy of sector visual field progression in OCT-based sector visual field simulation compared to actual visual field results. Measured in dB change over time.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

National Eye Institute (NEI)

Collaborator