Uddevalla Skövde Transscleral Micropulse Study

Primary Open Angle Glaucoma Clinical Trial

— USTMS  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05557721
• Other study ID #: USTMS
• Secondary ID: 278487
• Status: Enrolling by invitation
• Start date: October 6, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma

Intervention

Procedure:
• Topical lidocaine
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
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.

Locations

Country	Name	City	State
Sweden	Department of Ophthalmology, Skaraborg Hospital	Skövde	Vastra Gotaland
Sweden	Department of Ophthalmology, NU Hospital Group	Uddevalla	Vastra Gotaland

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	12 months
Secondary	Survival	Kaplan-Meier survival analysis regarding achievement and maintenance of "success" as defined above.	12 months
Secondary	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.	12 months
Secondary	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.	1 hour, 5 hours, and 24 hours postoperatively
Secondary	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.	1 month
Secondary	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.	3 months
Secondary	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).	1 month
Secondary	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).	1 month
Secondary	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.	12 months
Secondary	Adverse events	Suspected adverse events will be registered.	12 months