Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT01105065

First received: April 14, 2010

Last updated: February 13, 2013

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 14, 2010
Last Updated Date	February 13, 2013
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2010)	Presence or Absence of Retinal Blood Flow Autoregulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01105065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2010)	Improvement in Motion Detection [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma
Official Title ^ICMJE	Effect of Brimonidine 0.15% on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Tension Glaucoma
Brief Summary	The investigators have completed a study in which the investigators examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with Normal Tension Glaucoma (NTG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with NTG, this often does not occur. Upon analysis at the completion of the study , the investigators found that the patients who had been taking Alphagan (brimonidine) during the study did not exhibit the blood flow increases typical of NTG while lying down; instead, they maintained a steady blood flow rate as did the group of healthy control subjects. The investigators primary objective is to now demonstrate in a prospective study that Alphagan can restore retinal vascular autoregulatory function in patients with NTG who do not autoregulate. The investigators will also determine the effect of Alphagan treatment on the patients' ability to detect motion.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Drug: Alphagan (brimonidine) 0.15% One drop in each eye three times a day for 8 weeks. Other Name: Alphagan
Study Arm (s)	Experimental: Alphagan Intervention: Drug: Alphagan (brimonidine) 0.15%
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Eligible subjects will have no history of IOP > 24 mm Hg in either eye. All subjects will have open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. Previously or newly diagnosed patient are required to have HVFs that are reliable and show loss consistent with nerve fiber layer atrophy. Patients with glaucoma-like discs (CDR>0.7 in either eye) and normal/reliable visual fields who the PI has opted to observe without treatment will enter the study if they meet the other study criteria. In order to facilitate the retinal blood flow measurements, only subjects with refractive error within the range -10 to +10 diopters, no lens opacities greater than 1+ cortical spokes or 2+ nuclear sclerosis, and pupillary dilation of at least 6 mm following mydriasis will be included. Exclusion Criteria: Patients with evidence of exfoliation or pigment dispersion syndrome in either eye. Patients with a cup/disc ratio > 0.8. Known history of allergy to brimonidine. Patients already on treatment with brimonidine will be excluded from the study. Diabetic retinopathy. History of ocular laser or incisional surgery in either eye. Use of systemic alpha-2 blockers. Pregnant or planning to become pregnant.
Gender	Both
Ages	35 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01105065
Other Study ID Numbers ^ICMJE	10-03-019 (75643)
Has Data Monitoring Committee	Not Provided
Responsible Party	Massachusetts Eye and Ear Infirmary
Study Sponsor ^ICMJE	Massachusetts Eye and Ear Infirmary
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Massachusetts Eye and Ear Infirmary
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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