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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pattern Selective Laser Trabeculoplasty | Experimental | PSLT will be performed using the Pascal Streamline 577 laser (Topcon Inc., Tokyo, Japan). The laser spot is directed at the anterior chamber angle encompassing the pigmented and non-pigmented trabecular meshwork. Laser power is titrated by placing a laser mark in the lower quadrant with an exposure duration of 10 milliseconds (ms). The initial energy of 500 megawatts (mW) is selected and the power is reduced or increased until a slight whitening of the trabecular meshwork is minimally noticed. This power is then maintained and the pulse duration is automatically reduced to 5ms to produce invisible injury. The treatment is administered in 32 steps, each pattern consists of 36 stitches: 3 rows of 13 stitches each (total of 1152), with zero space between adjacent stitches. |
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| Prostaglandin analogue eye drops | Active Comparator | Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSLT | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure change | Intra-ocular pressure change will be similar in both groups | 1 week, 2 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Structural damage | Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed | 1 week, 9 months, 12 months |
| Functional damage | Changes in visual function as measured by computerized perimetry will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Pakter, MD, PhD | Contact | +55-51-991226968 | Hmpakter@hcpa.edu.br | |
| Rafaela Almeida, MD | Contact | rafaelacamposdealmeida@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Helena Pakter, MD. PhD | UFGRS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42418463 | Derived | de Almeida RCMC, Lindenmeyer RL, Lavinsky F, Lavinsky D, Picetti E, da Silva MO, Marinho DR, Moreira TS, Silveira VA, Leivas L, Meireles LDC, Pakter HM. Pascal selective laser trabeculoplasty (PSLT) in the treatment of ocular hypertension and open-angle glaucoma compared to travoprost eye drops: A non-inferiority clinical trial. PLoS One. 2026 Jul 8;21(7):e0350897. doi: 10.1371/journal.pone.0350897. eCollection 2026. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Prostaglandin analogue eye drops | Drug | Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye. |
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| 1 week, 9 months, 12 months |