N/A
N=23
Effect of Alphagan on Retinal Blood Flow Autoregulation and Motion Detection in Patients With Normal Pressure Glaucoma
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01105065 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Presence of Retinal Blood Flow Autoregulation — 14 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- brimonidine 0.15% (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Retinal Blood Flow Autoregulation |
14 | <0.0001 sig |
| SECONDARY Frequency Doubling Perimetry |
-2.03; -2.77 | 0.28 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01105065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.