Open Angle GlaucomaNCT05241938
PSLT Compared to Prostaglandin Analogue Eye Drops
A study testing PSLT and Prostaglandin analogue eye drops in people with Open Angle Glaucoma and Ocular Hypertension, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- PSLT and Prostaglandin analogue eye drops
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2021to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Rafaela Almeida, MD contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
Helena M Pakter, MD, PhD, hmpakter@hcpa.edu.br
About this study
Official title: Computer-guided Selective Laser Trabeculoplasty (PSLT) in the Treatment of Ocular Hypertension and Open-angle Glaucoma Compared to Prostaglandin Analogue Eye Drops: a Non-inferiority Randomized Clinical Trial
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
Read the 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.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- PSLT, Prostaglandin analogue eye drops
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSLTProcedure or surgery
Also called Pattern Selective Laser Trabeculoplasty
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).
Prostaglandin analogue eye dropsDrug
Also called Topical treatment
Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PSLT |
| Prostaglandin analogue eye drops | Active comparator | Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed Receives: Drug: Prostaglandin analogue eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure change
Intra-ocular pressure change will be similar in both groups
Measured: 1 week, 2 months, 9 months, 12 months
Secondary outcomes (2)
Structural damage
Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed
Measured: 1 week, 9 months, 12 months
Functional damage
Changes in visual function as measured by computerized perimetry will be assessed
Measured: 1 week, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Sep 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Messinger Pakter, Federal University of Rio Grande do Sul
- Investigators
- Helena Pakter, MD. PhD, Principal investigator, UFGRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241938
- Sponsor's protocol ID
- 44489320.7.0000.5327
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42418463
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-guided Selective Laser Trabeculoplasty (PSLT) in the Treatment of Ocular Hypertension and Open-angle Glaucoma Compared to Prostaglandin Analogue Eye Drops: a Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05241938
- Acronym / sponsor ID
- 44489320.7.0000.5327
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pattern Selective Laser Trabeculoplasty | Experimental | Procedure: PSLTPSLT 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. |
| Prostaglandin analogue eye drops | Active comparator | Drug: Prostaglandin analogue eye dropsProstaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSLTAlso: Pattern Selective Laser TrabeculoplastyPSLT 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). | Procedure or surgery | Pattern Selective Laser Trabeculoplasty |
| Prostaglandin analogue eye dropsAlso: Topical treatmentProstaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye. | Drug | Prostaglandin analogue eye drops |
Primary outcome
Intraocular pressure change
Time frame: 1 week, 2 months, 9 months, 12 months
Intra-ocular pressure change will be similar in both groups
2 secondary outcomes
Structural damage
Time frame: 1 week, 9 months, 12 months
Functional damage
Time frame: 1 week, 9 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 42418463de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafaela Almeida, MD contact
Helena Pakter, MD. PhD principal investigator
UFGRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSLT and Prostaglandin analogue eye drops in people with Open Angle Glaucoma and Ocular Hypertension, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Pakter, MD, PhD (+55-51-991226968, Hmpakter@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure change (time frame: 1 week, 2 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.