Functional and Structural Imaging for Glaucoma
Recruiting · NCT01957267 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Normal Subjects (both eyes must meet all 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
- Inclusion criteria: Glaucoma Group
- 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.
Exclusion criteria
- All Groups
- 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
Where it is running
1 location listed across 1 US state.
- Oregon Health & Science University, Casey Eye Institute - Portland, Oregon, United States