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

NCT06808633 | Recruiting

• 1 other identifier: 25/033-E
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Keywords

glaucoma; direct selective laser trabeculoplasty

Outcome Measures

Primary Outcomes (1)

• Percentage change in IOP six months after DSLT compared to baseline.

  Percentage change in IOP six months after DSLT compared to baseline.

  6 months after DLST application

Secondary Outcomes (5)

• Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.

  12 months

• Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.

  12 months

• Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.

  12 months

• Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months

  12 months

• Mean number of medications 3, 6 and 12 months after DSLT (accounting for those on no medications as well when calculating the average).

  12 months

Other Outcomes (1)

• Glaucoma Quality of Life-15 Questionnaire at 12 months after DSLT.

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with open angle glaucoma in study eye and scheduled for both eyes being treated after bilateral laser indication.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clínica Rementería: lead

Study Sites (1)

Clínica Rementería

Madrid, Madrid, 28010, Spain

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Inés Contreras

CONTACT

+34913083838; contreras@clinicarementeria.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: At the end of study (expected winter 2026) and for five years
• Access Criteria: Data deposited in a dataset repository, accessed by identified researchers

Locations

ES (1)