Brimonidine vs ALTP in Progressing Human Glaucoma

Study Overview
=================
Brief Summary
-----------------
This study is evaluating possible non-intraocular pressure (IOP) related effects of the alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.

Detailed Description
-----------------
Patients with open angle glaucoma and a history of relative stability of the visual field are followed for 18 months. A visual field is measured every 3 months for a total number of n = 6 eligible fields at the end of this phase. Then, those eyes showing progression of the field (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2% brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session. Either treatment will be put on top of the pre-existing anti-glaucoma therapy. Then, a further 18-month phase is planned, with a sequnece of field taken at the same pace as the previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e. regression vs time of single points and of clusters of adjacent points).

Official Title
-----------------
Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: brimonidine
* Procedure: laser trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucomatous visual field defect on achromatic perimetry (24/2 Humphrey full threshold,abnormal GHT and CPSD, p<0.01) considered clinically unstable IOP < 20 mmHg on repeated readings with no more than 2 medications, Open angle on gonioscopy, Glaucomatous optic neuropathy (HRTII, Moorfields regression analysis), Clear lens (LOCS2 score < C1, N0, P0) Best corrected visual acuity better than 0.2 LogMAR (ETDRS chart), No previous bulbar surgery Manifest refraction within - 5 and + 2 diopters No comorbidity (AMD and diabetic retinopathy.and negative history for neurological diseases) Exclusion Criteria: Closed angle Previous bulbar surgery Unstable IOP Unreliable visual fields on historic data

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: brimonidine|nan|
|Procedure: laser trabeculoplasty|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of visual field measured as loss of sensitivity in decibels per year |  |  | 
| progression of visual field measured as number of eyes showing at least one cluster of points progressing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of drop out(s) for adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroprotection, alpha one agonists, glaucoma, visual field