Clínica Rementería
Madrid, 28010, Spain
Location status: Recruiting
NCT Number: NCT06808633
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Madrid, 28010, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• Age over 18 years
Exclusion criteria
Time frame: 6 months after DLST application
Percentage change in IOP six months after DSLT compared to baseline.
Time frame: 12 months
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
Glaucoma Quality of Life-15 Questionnaire at 12 months after DSLT. It consists of 15 questions asking about patients difficulty for performing everyday tasks, which the patient must grade from 1 to 5, with 1 being that patient has no difficulty performing the task and 5 that he has severe diificulties. Values range from 15 (no difficulties for any activity) to 45 (has severe difficulties for performing all activities)
Contact information is provided by the study sponsor or research team.
Clínica Rementería
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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