Glaucoma Screening and Enrollment Protocol

Study subjects were screened in advance and then approached during their routine ophthalmology visits for written consent. A total of 22 subjects were enrolled in the study. Of those enrolled, two subjects failed to return to receive the experimental intervention and were subsequently lost to follow-up. 20 subjects and 37 eyes were included in the study. All subjects were 18 years or older and diagnosed with glaucoma or determined to be a glaucoma suspect. A diagnosis of glaucoma was based on the identification of clinical glaucomatous retinal nerve fiber layer (RNFL) defects and optic nerve head (ONH) abnormalities, including global rim thinning, rim notching, disc hemorrhage, or two consecutive reliable visual field tests with glaucoma hemifield test (GHT) showing a mean deviation outside normal limits. A diagnosis of glaucoma suspect was based on having glaucomatous optic neuropathy, as described for the diagnosis of glaucoma, and/or having ocular hypertension (IOP > 21 mm Hg) with a most recent visual field test with GHT showing a mean deviation within normal limits. Criteria for exclusion included the presence of corneal opacities, such as scars and edema, pregnancy or planning to be pregnant, and an inability to fixate gaze.
The trial registration information is as follows:
The CONSORT participant flow diagram is shown in Fig 1.