Ocular Hypertension, Open Angle Glaucoma
Conditions
Brief summary
This study aims to compare the efficacy of PSLT and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (OCT) related to pressure change resulting from treatments
Detailed description
Patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study. These patients will have both eyes included in the study. A randomization will be made to allocate one eye to receive treatment with PSLT (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control). Patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and OCT will be performed.
Interventions
PROCEDUREPSLT
PSLT will be performed under topical anesthesia (proxymetacaine hydrochloride 5mg/ml eye drops) using a mirrored gonioscopy lens (Latina Ocular Instruments). A α2 agonist hypotensive eye drops (0.2% brimonidine tartrate) and 2% pilocarpine eye drops are applied 40 minutes before the procedure. After laser treatment, the patient will be instructed to use non-steroidal anti-inflammatory eye drops (thrice daily for 7 days).
DRUGProstaglandin analogue eye drops
Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of ocular hypertension (IOP ≥ 24 mmHg in both eyes) or diagnosis of open-angle glaucoma (POAG) in both eyes * Proper visualization of angle structures and 360 degree open angles in both eyes * No previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation * No use of systemic medications known to increase IOP
Exclusion criteria
* Patients using more than two glaucoma medications * Evidence of any other eye disease that could affect IOP measurement * Diagnosis of other types of glaucoma * Patient with mean deviation (MD) less than -12 decibels (dB) on visual perimetry (severe disease) * Patients with unilateral glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure change | 1 week, 2 months, 9 months, 12 months | Intra-ocular pressure change will be similar in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural damage | 1 week, 9 months, 12 months | Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed |
| Functional damage | 1 week, 9 months, 12 months | Changes in visual function as measured by computerized perimetry will be assessed |
Countries
Brazil
Contacts
Primary ContactHelena Pakter, MD, PhD
Backup ContactRafaela Almeida, MD
Outcome results
None listed