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NCT01957267Recruiting

Functional and Structural Imaging for Glaucoma

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
249 (estimated)
First submitted
11 Sept 2013
Start date
Sept 2013
Primary completion date
May 2031
Lead sponsor
Oregon Health and Science University
Diseases
Glaucoma
NCT number
NCT01957267

What you commit to

  • Study type: Observational
  • Planned participants: 249
  • From Sept 2013 to the primary completion date, May 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Other diseases that may cause VF loss or optic disc abnormalities
  • Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.

Age

  • Age \< 40 or \>85 years

Other

  • Best-corrected visual acuity less than 20/40
  • Refractive error of \> +3.00 D or \< -7.00 D
  • Diabetic retinopathy
  • 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
  • Refusal of informed consent or of commitment to the full length of the study

Who the study is looking for

  • 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.

Age in the registry: 40 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oregon Health & Science University: Casey Eye Institute
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.