GlaucomaNCT06808633
Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
An observational study of Glaucoma, run by Clínica Rementería at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 20 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with open angle glaucoma in study eye and scheduled for both eyes being treated after bilateral laser indication.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica Rementería
Madrid, Madrid, 28010
Inés Contreras, +34913083838, contreras@clinicarementeria.es
About this study
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.
- Conditions
- Glaucoma
- Keywords
- glaucoma, direct selective laser trabeculoplasty
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Age over 18 years Diagnosis of open angle glaucoma instudy eye 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in IOP six months after DSLT compared to baseline.
Percentage change in IOP six months after DSLT compared to baseline.
Measured: 6 months after DLST application
Secondary outcomes (5)
Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.
Percentage change in washed-out IOP 3 and 12 months after DSLT compared to baseline.
Measured: 12 months
Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.
Mean washed-out IOP change 3, 6 and 12 months after DSLT compared to baseline.
Measured: 12 months
Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.
Proportion of participants with at least 20% reduction in washed-out IOP from baseline at 3, 6 and 12 months.
Measured: 12 months
Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months
Percentage of patients using hypotensive topical treatment after DSLT at 3, 6, and 12 months
Measured: 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).
Mean number of medications 3, 6 and 12 months after DSLT (accounting for those on no medications as well when calculating the average).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Rementería
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808633
- Sponsor's protocol ID
- 25/033-E
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, gender, baseline IOP, severity of glaucoma, IOP at each follow-up visit, need for glaucoma medications
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma
- ClinicalTrials.gov ID
- NCT06808633
- Acronym / sponsor ID
- 25/033-E
- Conditions
- Glaucoma
- Keywords
- glaucoma, direct selective laser trabeculoplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Clínica RementeríaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | – | –Age over 18 years Diagnosis of open angle glaucoma instudy eye 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with open angle glaucoma in study eye and scheduled for both eyes being treated after bilateral laser indication.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes. Age, gender, baseline IOP, severity of glaucoma, IOP at each follow-up visit, need for glaucoma medications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Clínica Rementería at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inés Contreras (+34913083838, contreras@clinicarementeria.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in IOP six months after DSLT compared to baseline. (time frame: 6 months after DLST application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.