Clinical trial NCT06808633: Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
Official title: Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Keywords: glaucoma
direct selective laser trabeculoplasty
Lead sponsor: Clínica Rementería
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria: • Age over 18 years

• 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)

Primary outcomes:
measure: Percentage change in IOP six months after DSLT compared to baseline.
timeFrame: 6 months after DLST application
Secondary outcomes:
measure: Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.
timeFrame: 12 months
measure: Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.
timeFrame: 12 months
measure: Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.
timeFrame: 12 months
measure: Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months
timeFrame: 12 months
measure: Mean number of medications 3, 6 and 12 months after DSLT (accounting for those on no medications as well when calculating the average).
timeFrame: 12 months
Other outcomes:
measure: Glaucoma Quality of Life-15 Questionnaire at 12 months after DSLT.
timeFrame: 12 months
Locations:
city: Madrid
country: Spain
facility: Clínica Rementería
Study officials:
References: