Phase 4 N=35 Randomized Single-blind Diagnostic

Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study

Glaucoma; Drugs · Normal Tension Glaucoma · Primary Open-angle Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT03323164 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography — -0.51; 2.59; -0.96; 0.96 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Timolol Maleate (Drug); Brimonidine Tartrate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wills Eye
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography	-0.51; 2.59; -0.96; 0.96; -0.04; 4.12	—
PRIMARY Changes in Flow Index in Treatment Groups Assessed by OCT Angiography	-5.23; 0.33; -12.55; 0.69; -4.87; 2.76	—
PRIMARY Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography	1.70; -0.51; -2.05; 2.59; 2.89; -1.62	—
PRIMARY Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography	2.35; -5.23; 1.61; 0.33; 12.81; -14.91	—
PRIMARY Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography	1.27; 1.08; 0.32; 0.91; 2.22; -1.00	—
PRIMARY Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography	2.69; -5.24; 1.96; -0.69; 12.40; -13.73	—

Summary

This study evaluates the possible acute changes in peripapillary blood flow after instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence Tomography (OCT) angiography.

Eligibility Criteria

Inclusion Criteria

Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension glaucoma in the study eye(s)
Age 18-90
Best corrected visual acuity of 20/60 or better

Exclusion Criteria

Current use of either brimonidine or timolol
Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT test in the study eye(s) including:
More than moderate grade cataract that significantly reducing OCTA scan signal level
Macular degeneration other than mild drusen or pigmentary changes
Diabetic retinopathy other than mild background non proliferative retinopathy
Prior or current macular edema
Prior laser treatment to the retina
Prior retinal detachment
Prior central serous retinopathy
Prior retinal vein or artery occlusion
Prior inflammatory retinopathy or choroidopathy
Keratoconus or other corneal ectasia
Corneal scarring in central 4 mm
Prior penetrating keratoplasty
Ischemic optic neuropathy
Dementia beyond early/mild memory loss
History of cerebrovascular accident
History of severe carotid stenosis
History of previous ocular surgery other than non-complicated cataract extraction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03323164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.