Glaucoma
Conditions
Keywords
neuroprotection, alpha one agonists, glaucoma, visual field
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).
Interventions
DRUGbrimonidine
PROCEDURElaser trabeculoplasty
Sponsors
University of Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| number of drop out(s) for adverse events | — |
Countries
Italy
Outcome results
None listed