NCT01957267 Functional and Structural Imaging for Glaucoma
| NCT ID | NCT01957267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Glaucoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 249 participants |
| Start Date | 2013-09-25 |
| Primary Completion | 2031-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 249 participants in total. It began in 2013-09-25 with a primary completion date of 2031-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Aiyin Chen, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT01957267 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01957267 currently recruiting?
Yes, NCT01957267 is actively recruiting participants. Contact the research team at deshpanc@ohsu.edu for enrollment information.
Where is the NCT01957267 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT01957267 clinical trial?
NCT01957267 is sponsored by Oregon Health and Science University. The principal investigator is Aiyin Chen, MD at Oregon Health and Science University. The trial plans to enroll 249 participants.