Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Percentage change in IOP six months after DSLT compared to baseline. [Time frame: 6 months after DLST application]
Secondary outcome measures (5)
- Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline. [Time frame: 12 months]
- Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline. [Time frame: 12 months]
- Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months. [Time frame: 12 months]
- Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months [Time frame: 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). [Time frame: 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Clínica Rementería — Madrid
Identifiers
NCT: NCT06808633 · 25/033-E