Functional and Structural Imaging for Glaucoma (NCT01957267) | Clinical Trial Compass
RecruitingNot Applicable
Functional and Structural Imaging for Glaucoma
United States160 participantsStarted 2013-09-25
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Measure of retinal non-perfusion areas in mm2
Timeframe: 5 years
2
Measure vessel density in percentage (%)
Timeframe: 5 years
3
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.