Diagnostic Innovations in Glaucoma Study

The Diagnostic Innovation in Glaucoma Study (DIGS) and ADAGES are longitudinal studies in which participants with or without myopia are examined approximately biannually, in most cases. Healthy controls with or without myopia are examined once, in most cases. The ADAGES recruitment and testing of individuals of African descent is an independently funded multi-center (including UCSD, Columbia University, and University of Alabama, Birmingham) study, which follows the same study protocol as the DIGS to ensure that the data from both studies can be analyzed together. This harmonization of protocols leverages the advantages of both DIGS by increasing the sample sizes to address the unique hypotheses of each study.

All participants must be 18 years old or older. Participants with or without myopia will be required to have at least one eye with open angles, best corrected visual acuity of 20/40 or better to be included. Participants taking a medication known to affect visual field sensitivity and eyes with a history of intraocular surgery (except uncomplicated glaucoma and cataract surgery), a secondary cause of elevated intraocular pressure, a coexisting intraocular disease affecting visual field, or a problem other than glaucoma affecting color vision may be excluded.

Most of the extensive testing completed for these visits can be considered standard of care, but for clinical care all tests are not generally all done at the same patient visit with the variety of instruments included in this research project. The following tests can be considered standard of care: medical history, blood pressure and heart rate, height and weight, visual acuity testing near acuity testing, low contrast sensitivity testing, slit lamp biomicroscopy (including gonioscopy), measurements of intraocular pressure with contact and non-contact tonometry, corneal thickness measurement (pachymetry), corneal elasticity measured using non-contact tonometry, interocular axial length, corneal curvature, anterior chamber depth measurements (all measured using intraocular lens IOL master), dilated fundoscopy, stereoscopic ophthalmoscopy of the optic disc with a 78 D lens, color vision testing, standard automated perimetry, optical coherence tomography (OCT) and photography.

There is currently no end date to the study, as the follow-up will continue as long as the research is supported.

The time involved is usually 2-4 visits per year of approximately 2-5 hours each.

DIGS Positional Study Subjects will also be given the opportunity to participate in the following additional auxiliary study. The DIGS Positional Study will allow subjects to participate in an ancillary study. Participation in this ancillary study includes imaging of the eyes using Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCT-A), as well as measurement of intraocular pressure (IOP) and blood pressure (BP) in sitting and supine positions. No invasive procedures or treatments will be administered. We will be using the standard clinically available software as well as investigational software available for research purposes. The investigational software has been deemed safe by the manufacturer of the device and does not pose any additional risks to patients. Since not every glaucoma patient has high eye pressure (low-tension glaucoma) or has pressure controlled with medication use (so that the untreated eye pressure is now known), glaucoma subjects using intraocular pressure lowering medication and with IOP < 25 mm Hg may be requested to stop their medication for 1 to 3 weeks, by the treating ophthalmologist depending on the class of medication, before being imaged. Risks are small and include IOP elevation. However, glaucoma progression is on the order of months to years, and not days. Subjects will resume using the medication after the research visit is completed.

Inclusion:

• Subjects are healthy controls with or without myopia, and patients with or without myopia with a diagnosis of glaucoma, glaucoma suspect and ocular hypertension
• They will be considered if they are above 18 years old.
• There is no upper age limit
• Subject are not restricted by gender, race or ethnicity.

Exclusion:

-Participants with other ocular or systemic conditions and treatment, which may affect visual function, are excluded.