Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, single-arm, single-center, non-randomized, non-comparative study including naïve patients attending our center diagnosed with glaucoma, who have been recommended treatment with direct selective laser trabeculoplasty (DSLT) by their ophthalmologist and who are under no hypotensive medication. DSLT treatment will be performed with the Voyager DSLT system; it will consist of the application of 120 laser pulses of preset 3 ns and a preset 400 μm spot size, with an energy of 1.8 mJ delivered to the limbus through a full 360 degrees.

The study will evaluate the effect of DSLT on intraocular pressure (IOP). Baseline IOP will be the IOP measured with Goldman applanation tonometry by the investigator on the day of treatment, prior to the application of DSLT. Patients will be seen one week (±2 days), one month (±7 days), three months (±15 days), six months (±30 days) and 12 months (±40 days) after DSLT treatment. In each of these visits, the attending ophthalmologist will measure IOP with Goldmann applanation tonometry and record the presence of any relevant ocular signs and query patients regarding potential adverse events. The study´s main end-point will be percentage reduction in IOP six months after DSLT compared to baseline.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Efficacy of Selecta Laser Trabeculoplasty in Patients Undergoing Filtering Surgery

NCT05900063

Glaucoma

COMPLETED

IOP Reduction in Pigmentary Glaucoma Using DSLT

NCT07281391

Pigmentary Dispersion Syndrome Pigmentary Dispersion Glaucoma

NOT_YET_RECRUITING

Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)

NCT00801658

Glaucoma

COMPLETED PHASE4

Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment

NCT06819046

Glaucoma

RECRUITING

A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Pressure (IOP) Reduction Without Medications at 6 Months in Naive, Untreated Glaucoma Patients

NCT07076303

Primary Open Angle Glaucoma Glaucoma Primary Open Angle Glaucoma or Ocular Hypertension

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study participants

Age over 18 years Diagnosis of open angle glaucoma instudy eye and scheduled for both eyes being treated after bilateral laser indication. The diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an IOP value\>21 mmHg.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Diagnosis of open angle glaucoma in eye study and scheduled for both eyes being treated after bilateral laser indication. The diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an IOP value\>21 mmHg.

Exclusion Criteria

* Patients diagnosed with uveitis, angle closure or congenital glaucoma.
* Presence of anterior peripheral synechiae
* Patients unable to complete three, six- and 12-months follow-up.
* Patients having undergone intraocular surgery, save for uneventful phacoemulsification (performed at least 6 months prior to inclusion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No