Clinical Trials Directory

Trials / Completed

CompletedNCT03323164

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

Changes in Peripapillary Blood Flow After Use of Anti-glaucoma Medications: A Prospective, Quantitative OCT Angiography Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Wills Eye · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Detailed description

Reduction of intraocular pressure (IOP) with topical antihypertensive medications is the mainstay of initial treatment in patients with OHTN, POAG, and NTG. Many patients, however, continue to experience disease progression despite IOP reduction. Alternative mechanisms of neurodegeneration, including vascular dysregulation and structural susceptibility of the lamina cribrosa, have been proposed as important mechanisms in progression, particularly in cases of NTG. Prior studies have also found decreased calculated mean ocular perfusion with the use of timolol compared to other antiglaucoma medications in patients with normal tension glaucoma. Visual field deterioration has also been shown to be associated with systemic nocturnal arterial hypotension in patients with NTG, POAG, and after anterior ischemic optic neuropathy. The use of ophthalmic topical beta-blockers has been shown to lower nocturnal diastolic blood pressure and heart rate. Thus, topical beta blockers are often avoided in the treatment of NTG due to the potential risk of reduced optic nerve head perfusion Studies evaluating optic nerve head (ONH) perfusion are limited. Earlier studies evaluated indirect measurements, such as calculated mean ocular perfusion pressure or systemic hypotension, as indications of optic nerve hypoperfusion. Direct measurements of ocular perfusion have been attempted using retrobulbar color Doppler imaging, which demonstrated decreased short posterior ciliary artery flow velocity in patients with glaucomatous visual field progression. This technique, however, has yielded inconsistent results in other studies, and is only capable of detecting gross changes to ocular blood flow. Optical Coherence Tomography Angiography (OCTA) is a novel technique first introduced in 2014 using a custom swept-source OCT system.No studies currently exist to evaluate the effects of antiglaucoma medications on peripapillary blood flow using OCTA.

Conditions

Interventions

TypeNameDescription
DRUGTimolol MaleateInstillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
DRUGBrimonidine TartrateInstillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.

Timeline

Start date
2017-07-10
Primary completion
2018-12-31
Completion
2020-05-30
First posted
2017-10-26
Last updated
2020-12-31
Results posted
2020-12-31

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03323164. Inclusion in this directory is not an endorsement.