Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Drug: Alphagan (brimonidine) 0.15% |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Brimonidine 0.15% on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Tension Glaucoma |
- Presence or Absence of Retinal Blood Flow Autoregulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Improvement in Motion Detection [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Alphagan |
Drug: Alphagan (brimonidine) 0.15%
One drop in each eye three times a day for 8 weeks.
Other Name: Alphagan
|
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Massachusetts Eye and Ear Infirmary |
| ClinicalTrials.gov Identifier: | NCT01105065 History of Changes |
| Other Study ID Numbers: | 10-03-019 (75643) |
| Study First Received: | April 14, 2010 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts Eye and Ear Infirmary:
|
Normal Pressure Glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Low Tension Glaucoma Ocular Hypertension Eye Diseases Optic Nerve Diseases Brimonidine Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013