Functional and Structural Imaging for Glaucoma

NCT01957267 | Recruiting DMC

• 2 other identifiers: OHSU IRB #000097291R01EY023285
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Measure of retinal non-perfusion areas in mm2

  5 years

• Measure vessel density in percentage (%)

  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.

  5 years

Study Arms (2)

Glaucoma Group

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

Normal Group

Volunteers with healthy eyes

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Diabetic retinopathy
• Other diseases that may cause VF loss or optic disc abnormalities
• Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
• Inability to perform reliably on automated VF testing
• Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
• Refusal of informed consent or of commitment to the full length of the study

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, 97214, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Aiyin Chen, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinmay Deshpande, M.Optom.

CONTACT

503-494-9628; deshpanc@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aiyin Chen, MD, Professor of Ophthalmology, Oregon Health & Science University

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 8, 2013
• Study Start: September 25, 2013
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)