Uddevalla Skövde Transscleral Micropulse Study

NCT05557721 | Enrolling By Invitation

• 2 other identifiers: USTMS278487
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma

Keywords

Micro pulse transscleral laser treatment (MP-TLT)

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• 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.

  6 months

• 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.

  Immediately after surgery

Secondary Outcomes (10)

• Success proportion after 12 months

  12 months

• Survival

  12 months

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

  12 months

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

  1 hour, 5 hours, and 24 hours postoperatively

• Patient reported discomfort on an arbitrary scale

  1 month

Study Arms (1)

MP-TLT in topical anesthesia

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. 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.

Procedure: Topical lidocaine; Procedure: MP-TLT

Interventions

Topical lidocaine PROCEDURE

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-TLT in topical anesthesia

MP-TLT PROCEDURE

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.

MP-TLT in topical anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients referred for MP-TLT at the ophthalmology departments of the NU Hospital Group and the Skaraborg Hospital are recruited sequentially.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Department of Ophthalmology, Skaraborg Hospital

Skövde, Västra Götaland County, 54142, Sweden

Location

Department of Ophthalmology, NU Hospital Group

Uddevalla, Västra Götaland County, 45153, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35698599 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tobias Dahlgren, MD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

• Marcelo Ayala, MD, PhD

  Vastra Gotaland Region

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 28, 2022
• Study Start: October 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)