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Trial record 2 of 10 for:    daniel lee | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03323164
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Optovue
Information provided by (Responsible Party):
Daniel Lee, Wills Eye

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma; Drugs Normal Tension Glaucoma Primary Open-angle Glaucoma Drug: Timolol Maleate Drug: Brimonidine Tartrate Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Changes in Peripapillary Blood Flow After Use of Anti-glaucoma Medications: A Prospective, Quantitative OCT Angiography Study
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Active Comparator: Timolol
Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.
Drug: Timolol Maleate
Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Other Name: Timolol
Active Comparator: Brimonidine
Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.
Drug: Brimonidine Tartrate
Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
Other Name: Brimonidine



Primary Outcome Measures :
  1. Changes in peripapillary blood flow assessed by OCT angiography [ Time Frame: 2 hours ]
    Acute quantitative change in peripapillary vessel density and/or blood flow index detected by OCT Angiography using SSADA algorithm with the use of topical brimonidine or timolol.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323164


Contacts
Contact: Mary Jo Schwartz 215-928-3123 MSchwartz@willseye.org

Locations
United States, Pennsylvania
Glaucoma Research Center - Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mary Jo Schwartz    215-928-3123    MSchwartz@willseye.org   
Sponsors and Collaborators
Wills Eye
Optovue
Investigators
Principal Investigator: Daniel Lee, MD Wills Eye Hospital

Responsible Party: Daniel Lee, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT03323164     History of Changes
Other Study ID Numbers: 17-636E
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Timolol
Brimonidine Tartrate
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists