USTMS: Uddevalla Skövde Transscleral Micropulse Study
Study Details
Study Description
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. Furthermore, the study will evaluate the effectiveness of two alternate methods of anesthesia before MP-TLT. Patients will be randomized to receive either sub-tenon anesthesia with lidocaine injection or topical anesthesia with lidocaine gel.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Forty patients scheduled for MP-TLT by their ophthalmologist will be recruited. Patients will be randomized to receive either topical anesthesia with 2% lidocaine gel or a sub-tenon injection with 2 ml of 1% lidocaine, in addition to tetracaine drops. One eye per patient is included, based on randomization, even if both are treated.
MP-TLT will be performed according to the current recommendations for both groups.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sub-tenon lidocaine Patients will receive topical anesthesia with tetracaine hydrochloride 1% three times, 5 minutes apart. Then, sub-tenon anaesthesia with 2 ml lidocaine 1% will be performed. After 10 minutes of waiting time, MP-TLT will be performed. |
Procedure: Sub-tenon lidocaine
See arm description.
Procedure: 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.
|
| Experimental: 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. Thereafter, MP-TLT will be performed. |
Procedure: Topical lidocaine
See arm description.
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Relative IOP change (percent) [6 months]
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.
- Relative IOP change (percent) for POAG and PXFG eyes separately [6 months]
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.
- Perioperative pain on a visual analogue scale (VAS), comparison between arm 1 and 2 [Immediately after surgery]
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. Comparison between arm 1 and 2. If there was a need for supplementary anesthesia, the grading applies to the experience before supplementation.
Secondary Outcome Measures
- Success proportion after 12 months [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.
- Survival [12 months]
Kaplan-Meier survival analysis regarding achievement and maintenance of "success" as defined above.
- Relative change (percent) of the IOP 1 week, 1 month, 3 months and 12 months after MP-TLT. [12 months]
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.
- Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively [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. Comparison between arm 1 and 2 will be performed regarding each time point.
- Patient reported discomfort on an arbitrary scale [1 month]
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 between arm 1 and 2.
- Change in central retinal thickness (CRT) postoperatively [3 months]
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.
- Change in central corneal thickness (CCT) postoperatively [1 month]
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).
- Change of flare in the anterior chamber postoperatively [1 month]
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).
- Change in visual field index (VFI) during follow-up [12 months]
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.
- Adverse events [12 months]
Suspected adverse events from MP-TLT or anesthesia will be registered for the patients in arm 1 and 2. This will be reported as a list for each arm.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of primary open angle glaucoma (POAG) or pseudo exfoliative glaucoma (PXFG)
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Age ≥ 18 years
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The patient is expected to be able to adequately undergo and cooperate in the treatment and follow-up as described in the study protocol.
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The patient is judged to have good compliance with already prescribed pharmacological glaucoma treatment.
Exclusion Criteria:
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Allergy or hypersensitivity to tetracaine or lidocaine
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Prior transscleral laser or cryo treatment.
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Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months.
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Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year.
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History of macular edema.
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History of corneal edema.
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History of uveitis during the past year.
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Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ophthalmology, Skaraborg Hospital | Skövde | Vastra Gotaland | Sweden | 54142 |
| 2 | Department of Ophthalmology, NU Hospital Group | Uddevalla | Vastra Gotaland | Sweden | 45153 |
Sponsors and Collaborators
- Vastra Gotaland Region
- Göteborg University
Investigators
- Principal Investigator: Tobias Dahlgren, MD, Vastra Gotaland Region
- Study Chair: Marcelo Ayala, MD, PhD, Vastra Gotaland Region
Study Documents (Full-Text)
None provided.More Information
Publications
- USTMS
- 278487