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

Information source: Massachusetts Eye and Ear Infirmary
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Alphagan (brimonidine) 0.15% (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts Eye and Ear Infirmary

Overall contact:
Louis R Pasquale, MD, Phone: 617-573-4270, Email: Louis_Pasquale@meei.harvard.edu

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.

Clinical Details

Official title: Effect of Brimonidine 0.15% on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Tension Glaucoma

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Presence or Absence of Retinal Blood Flow Autoregulation

Secondary outcome: Improvement in Motion Detection

Eligibility

Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Louis R Pasquale, MD, Phone: 617-573-4270, Email: Louis_Pasquale@meei.harvard.edu

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts 02114, United States; Recruiting
Louis R Pasquale, MD, Principal Investigator
Additional Information

Starting date: March 2010
Last updated: April 10, 2012

Page last updated: February 07, 2013

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