OHSU

IRB #

IRB00009729

Title

Longitudinal observational study using functional and structural optical coherence tomography to diagnose and guide treatment of glaucoma

Principal Investigator

John Morrison

Study Purpose

To use ultrahigh-speed OCT technology to measure ocular blood flow and provide OCT angiography in order to improve the accuracy of diagnosis and guidance of the treatment of glaucoma.

Medical Condition(s)

Glaucoma

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: Perimetric Glaucoma (PG) Group (one or both eyes must meet all criteria)
1) ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
a. diffuse or localized thinning of the rim
b. disc (splinter) hemorrhage
c. notch in the rim
d. vertical cup/disc ratio greater than the fellow eye by > 0.2

2) Consistent glaucomatous pattern on both qualifying Humphrey SITA 24-2 VF meeting at least one of the following quantitative criteria for abnormality:
a. PSD outside normal limits (p < 0.05)
b. GHT outside normal limits (p < 0.01)

Inclusion Criteria: Glaucoma Suspect (GS) and Pre-perimetric Glaucoma (PPG) Group (both eyes must meet at least one criterion)
GS participants must have at least one eye with one of the following risk factors:
1) Ocular hypertension is defined by a baseline IOP ≥ 22 mmHg, or if already treated by IOP lowering medication at the baseline examination, a pre-treatment IOP ≥ 22 recorded within 2 years of enrollment.
2) The fellow eye meeting the eligibility criteria for the PG group.

In addition, GS eyes must meet all of the following criteria:
1) Baseline VF not meeting the criteria for the PG group.
2) Normal ONH and NFL appearance on baseline biomicroscopic examination: intact neuroretinal rim without splinter hemorrhages, notches, localized pallor, or NFL defect.
3) Cup-to-disc ratio difference between 2 eyes must be < 0.2 in both vertical and horizontal dimensions on baseline biomicroscopy.

PPG participants must have at least one eye meeting all of the following criteria:
1) ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
a. diffuse or localized thinning of the rim
b. disc (splinter) hemorrhage
c. notch in the rim
d. well-defined peripapillary NFL bundle defect.
e. vertical cup/disc ratio (CDR) > 0.6, inter-eye vertical CDR asymmetry > 0.2
2) Baseline VF not meeting the criteria for the PG group.

Exclusion criteria: All Groups
1) Best-corrected visual acuity less than 20/40
2) Age < 40 or >80 years
3) Refractive error of > +3.00 D or < -7.00 D
4) Previous intraocular surgery except for uncomplicated 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

Age Range

40 - 79

Healthy Volunteers Needed

Yes

Duration of Participation

5 years

Minors Included

No

Contact

Janice Ladwig
503-494-8024

Sponsor

N/A

Recruitment End

09/01/2015

Compensation Provided

Yes

Compensation

Healthy volunteers will be compensated $50 per year.


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