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NCT Number: NCT06808633

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months after DLST application

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

Secondary outcomes

  1. Percentage change in washed-out IOP 3 and 12 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.

  2. Mean washed-out IOP change 3, 6 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.

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

    Time frame: 12 months

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

  4. Percentage of patients using hypotensive topical treatment after DSLT 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

  5. 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

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

Other outcomes

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Inés Contreras

CONTACT

[email protected]

+34913083838

Sponsors and collaborators

Lead sponsor

Clínica Rementería

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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