Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
Recruiting · NCT06808633 · Observational (researchers observe without assigning treatment) · Lead sponsor: Clínica Rementería
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- Clínica Rementería - Madrid, Madrid, Spain