Recruiting

Glaucoma Imaging

Sponsor:

Oregon Health and Science University

Code:

NCT01957267

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Glaucoma

Study ID

NCT01957267

Start date

Sep 25, 2013

Status verified date

Sep, 2026

Completion date

May 31, 2031

Anticipated

Primary completion date

May 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria: Normal Subjects (both eyes must meet all criteria)

1. No history or evidence of retinal pathology or glaucoma
2. 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%).
3. Intraocular pressure < 21 mm Hg
4. Central corneal pachymetry > 500 microns
5. No chronic ocular or systemic corticosteroid use
6. Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
7. 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
8. Symmetric ONH between left and right eyes: CDR difference < 0.2 in both vertical and horizontal dimensions

Inclusion criteria: Glaucoma Group

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

1. diffuse or localized thinning of the rim
2. disc (splinter) hemorrhage
3. notch in the rim
4. vertical cup/disc ratio greater than the fellow eye by > 0.2
2. Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF.

Exclusion Criteria: All Groups

1. Best-corrected visual acuity less than 20/40
2. Age < 40 or >85 years
3. Refractive error of > +3.00 D or < -7.00 D
4. Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
5. Diabetic retinopathy
6. Other diseases that may cause VF loss or optic disc abnormalities
7. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
8. Inability to perform reliably on automated VF testing
9. Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
10. Refusal of informed consent or of commitment to the full length of the study

Study Design

Enrollment

249 participants

Anticipated

Interventions and Outcome Measures

Arms

Glaucoma Group

Patients with clinically confirmed glaucomatous ONH or NFL defects, with or without VF abnormalities

Normal Group

Volunteers with healthy eyes

Primary outcome measure

  • Measure of retinal non-perfusion areas in mm2 [ Time Frame: 5 years ]
  • Measure vessel density in percentage (%) [ Time Frame: 5 years ]
  • 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 ]

Central Contacts and Locations

Central contacts

Chinmay Deshpande, M.Optom.

503-494-9628deshpanc@ohsu.edu

Locations

Oregon Health & Science University, Casey Eye Institute

Recruiting

Portland, Oregon, United States, 97214

Contacts

Chinmay Deshpande, M.Optom.

503-494-9628deshpanc@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Glaucoma
  • Optical Coherence Tomography
  • Intraocular pressure
  • Optic nervehead
  • Nerve fiber layer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-09-09.