Uddevalla Skövde Transscleral Micropulse Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Relative IOP change (percent) [Срок оценки: 6 months]
• Relative IOP change (percent) for POAG and PXFG eyes separately [Срок оценки: 6 months]
• Perioperative pain on a visual analogue scale (VAS) [Срок оценки: Immediately after surgery]

Вторичные конечные точки (10)

• Success proportion after 12 months [Срок оценки: 12 months]
• Survival [Срок оценки: 12 months]
• Relative change (percent) of the IOP 1 week, 1 month, 3 months and 12 months after MP-TLT. [Срок оценки: 12 months]
• Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively [Срок оценки: 1 hour, 5 hours, and 24 hours postoperatively]
• Patient reported discomfort on an arbitrary scale [Срок оценки: 1 month]
• Change in central retinal thickness (CRT) postoperatively [Срок оценки: 3 months]
• Change in central corneal thickness (CCT) postoperatively [Срок оценки: 1 month]
• Change of flare in the anterior chamber postoperatively [Срок оценки: 1 month]
• Change in visual field index (VFI) during follow-up [Срок оценки: 12 months]
• Adverse events [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 2 центра

• Department of Ophthalmology, Skaraborg Hospital — Skövde
• Department of Ophthalmology, NU Hospital Group — Uddevalla

Публикации

• 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

Идентификаторы

NCT: NCT05557721 · USTMS · 278487

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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