Improving imaging techniques for glaucoma detection
Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma
This study is testing new imaging techniques to see if they can help doctors better detect and monitor glaucoma, especially in patients who have normal eye pressure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT01957267 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the diagnosis and monitoring of glaucoma by developing advanced imaging technologies, including high-resolution optical coherence tomography (OCT) and OCT angiography. It focuses on validating these technologies to improve early detection of glaucoma and simulate visual field results by combining structural and angiographic data. The study addresses the limitations of current diagnostic tests, which often fail to accurately identify glaucoma, especially in patients with normal intraocular pressure. By exploring the role of blood flow imaging, the research seeks to provide a more objective assessment of glaucoma progression.
Who should consider this trial
Good fit: Ideal candidates include individuals with no history of retinal pathology or glaucoma and those with normal eye health parameters.
Not a fit: Patients with existing glaucoma or significant retinal pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of glaucoma, potentially preventing vision loss in patients.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for glaucoma detection, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- Oregon Health & Science University, Casey Eye Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Aiyin Chen, MD — Oregon Health and Science University
- Study coordinator: Chinmay Deshpande, M.Optom.
- Email: deshpanc@ohsu.edu
- Phone: 503-494-9628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.