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Primary Open Angle GlaucomaUSTMSNCT05557721

Uddevalla Skövde Transscleral Micropulse Study

An observational study of Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Vastra Gotaland Region at 2 sites in Sweden.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Topical lidocaine and MP-TLT
Type of treatment
Surgery or procedure
How many people
40 participants
Where
2 sitesSweden
Study dates
6 Oct 2023to 31 Dec 2025
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: 40 patients referred for MP-TLT at the ophthalmology departments of the NU Hospital Group and the Skaraborg Hospital are recruited sequentially.

Who may be able to join

  • Diagnosis of primary open angle glaucoma (POAG) or pseudo exfoliative glaucoma (PXFG)
  • Age ≥ 18 years
  • The patient is expected to be able to adequately undergo and cooperate in the treatment and follow-up as described in the study protocol.
  • The patient is judged to have good compliance with already prescribed pharmacological glaucoma treatment.

Who cannot join

  • Allergy or hypersensitivity to tetracaine or lidocaine
  • Prior transscleral laser or cryo treatment.
  • Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months.
  • Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year.
  • History of macular edema.
  • History of corneal edema.
  • History of uveitis during the past year.
  • Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden2 sites

  • Department of Ophthalmology, Skaraborg Hospital

    Skövde, Västra Götaland County, 54142

  • Department of Ophthalmology, NU Hospital Group

    Uddevalla, Västra Götaland County, 45153

Other trials in Sweden

About this study

Official title: Uddevalla Skövde Transscleral Micropulse Study: Efficacy and Safety of Micro Pulse Transscleral Laser Treatment (MP-TLT) in Glaucoma Patients Performed in Topical Lidocaine Anaesthesia

Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022.

The overall objective is to evaluate the efficacy and safety of the proposed treatment method in an independent study. In addition, the outcome of MP-TLT in patients with pseudoexfoliation glaucoma, which is relatively common in the Nordic countries, and primary open angle glaucoma will be studied separately.

The IOP change over the course of one year will be monitored, as well as success rate and survival. Further, patient-reported discomfort from the treatment and the occurrence of any adverse events or complications will be studied.

Read the detailed description

Forty patients scheduled for MP-TLT by their ophthalmologist will be recruited. One eye per patient is included, based on randomization, even if both are treated. MP-TLT will be performed according to the current recommendations.

Baseline IOP will be calculated as the mean of three separate measurements taken on different days preoperatively. IOP will then be measured 1 week, 1 month, 3 months, 6 months and 12 months after MP-TLT.

The central corneal thickness (CCT), the central retinal thickness (CRT), anterior chamber flare and the visual field (HFA 24-2 faster) will also be measured preoperatively and during follow up.

In accordance with the World Glaucoma Association guidelines, no adjustment for multiple comparisons is planned in this study.

Being tested
Topical lidocaine, MP-TLT
Keywords
Micro pulse transscleral laser treatment (MP-TLT)
Medical subject headings
Glaucoma, Open-Angle, Exfoliation Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical lidocaineProcedure or surgery

    Patients will receive topical anesthesia with tetracaine hydrochloride 1% three times, 5 minutes apart. Then, lidocaine gel 2% will be applied on the surface of the eye and refilled as needed for 10 minutes, as well as manipulated for a good coverage.

  • MP-TLTProcedure or surgery

    Micro pulse transscleral laser treatment will be performed with the Iridex CycloG6 laser with the revised P3 probe, according to the recent consensus recommendations.

    In brief, this includes MP-TLT with 2500 mW, 31.3% duty cycle, four 20 second sweeps per hemisphere, avoiding the 3 and 9 o'clock meridians and sectors with scleral thinning.

Study groups in NCT05557721
Study groupRoleWhat they receive
MP-TLT in topical anesthesiaPatients will receive topical anesthesia with tetracaine hydrochloride 1% three times, 5 minutes apart. Then, lidocaine gel 2% will be applied on the surface of the eye and refilled as needed for 10 minutes, as well as manipulated for a good coverage. Thereafter, MP-TLT will be performed with the Iridex CycloG6 laser with the revised P3 probe, according to the recent consensus recommendations. In brief, this includes MP-TLT with 2500 mW, 31.3% duty cycle, four 20 second sweeps per hemisphere, avoiding the 3 and 9 o'clock meridians and sectors with scleral thinning.
Receives: Procedure: Topical lidocaine; Procedure: MP-TLT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative IOP change (percent)

    Relative IOP (intraocular pressure) change (percentage relative to baseline) for the entire study population. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.

    Measured: 6 months

  2. Relative IOP change (percent) for POAG and PXFG eyes separately

    Relative IOP change (percentage relative to baseline) for the eyes with a diagnosis of primary open angle glaucoma, or pseudo exfoliative glaucoma, respectively. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.

    Measured: 6 months

  3. Perioperative pain on a visual analogue scale (VAS)

    The patient will report pain during MP-TLT treatment on a VAS immediately after surgery.

    A 10 cm horizontal line without markings will be presented. One end of the line represents "no pain" and the other "worst imaginable pain". The patient marks the position on the scale that corresponds to the level of perceived pain. The number of millimeters from the "no pain" end is the result. Higher is worse.

    If there was a need for supplementary anesthesia, the grading applies to the experience before supplementation.

    Measured: Immediately after surgery

Secondary outcomes (10)

  1. Success proportion after 12 months

    Eyes will be graded with either "success" or "failure" after one year of follow up. Definition of success (all must be fulfilled):

    • Reduction of the IOP by at least 20% compared to baseline and/or reduction in pharmacological glaucoma treatment.
    • IOP ≥ 6 mmHg
    • No additional IOP reducing intervention performed after MP-TLT.

    Measured: 12 months

  2. Survival

    Kaplan-Meier survival analysis regarding achievement and maintenance of "success" as defined above.

    Measured: 12 months

  3. Relative change (percent) of the IOP 1 week, 1 month, 3 months and 12 months after MP-TLT.

    IOP change relative to baseline 1 week, 1 month, 3 month and 12 months after MP-TLT. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.

    Measured: 12 months

  4. Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively

    Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively. See above for further description.

    Measured: 1 hour, 5 hours, and 24 hours postoperatively

  5. Patient reported discomfort on an arbitrary scale

    The patients will report peri- and postoperative pain, postoperative light sensitivity, visual impairment and hyperemia. The scale goes between 0 (no sensation) and 4 (worst imaginable). The scale was developed for the OSLT trial (NCT03798223). Comparisons will be made with the results from that trial.

    Measured: 1 month

  6. Change in central retinal thickness (CRT) postoperatively

    The thickness in the central retinal field will be measured with optical coherence tomography (OCT) at baseline and 1 week, 1 month and 3 months postoperatively. The relative change (percent) will be calculated for each time point.

    Measured: 3 months

  7. Change in central corneal thickness (CCT) postoperatively

    The central corneal thickness (CCT) in the thinnest point will be measured with Pentacam at baseline and 1 week and 1 month postoperatively. The relative change (percent) will be calculated for each time point. Applies only to NU patients (one of the centers).

    Measured: 1 month

  8. Change of flare in the anterior chamber postoperatively

    Flare in the anterior chamber will be measured with a Kowa laser flare meter at baseline and 1 week and 1 month postoperatively. The relative change (percent) will be calculated for each time point. Applies only to SkaS patients (one of the centers).

    Measured: 1 month

  9. Change in visual field index (VFI) during follow-up

    The visual field will be assessed with a Humphrey field analyzer (HFA) 24-2 faster at baseline and then 1 and 12 months postoperatively. The change in VFI, expressed in percentage points, will be calculated for each time point.

    Measured: 12 months

  10. Adverse events

    Suspected adverse events will be registered.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start6 Oct 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557721
Sponsor's protocol ID
USTMS
Other IDs
278487
Acronym
USTMS
Status last verified
Nov 2024
First submitted
19 Sep 2022
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grippo TM, de Crom RMPC, Giovingo M, Toteberg-Harms M, Francis BA, Jerkins B, Brubaker JW, Radcliffe N, An J, Noecker R. Evidence-Based Consensus Guidelines Series for MicroPulse Transscleral Laser Therapy: Dosimetry and Patient Selection. Clin Ophthalmol. 2022 Jun 7;16:1837-1846. doi: 10.2147/OPTH.S365647. eCollection 2022.

    PubMed 35698599

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Vastra Gotaland Region at 2 sites in Sweden.

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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative IOP change (percent) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557721, which also lists 1 linked publication.

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 3 Dec 2024.

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