Clarifying the Optimal Application of SLT Therapy Trial

Обзор

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.

Вмешательства

• Процедура Low Energy SLT
  SLT performed at low energy
• Процедура Standard Energy SLT
  SLT performed at standard energy

Первичные конечные точки

• 12-month survival [Срок оценки: 12 months]
• 48-month survival [Срок оценки: 48 months]

Вторичные конечные точки (3)

• Mean IOP [Срок оценки: 12 months]
• Long-term mean IOP [Срок оценки: 12, 24, 36, and 48 months]
• Incidence of IOP spikes [Срок оценки: 0, 12, 24, 36, and 48 months]

Критерии участия

Критерии включения

• Age 18 or older and in good health
• Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):

• High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes)
• Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 dB with no points in the central 5° <15 dB (see figure on next page)
• Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5° points <15 dB or mean deviation -12.0 dB or better with 1 central 5° points <15 dB (see figure on next page).
• Each eye with BCVA 20/200 (UK 6/60) or better

Критерии исключения

• Use of topical IOP-lowering medications for more than 6 cumulative months at any time in the past 5 years (this is a modification implemented during active enrollment)
• Any history of IOP-lowering laser (prophylactic iridotomy not included) or surgical procedure
• Advanced POAG in either eye (worse than moderate POAG as defined above)
• Glaucoma other than POAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
• Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
• Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
• Contraindications to SLT or any other study intervention
• Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
• Any intraocular surgical procedure within the past 6 months in either eye
• Inability to attend all scheduled study visits
• Pregnant or planning to become pregnant in the next 4 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 28 центров

• Harvard Eye Associates — Laguna Hills
• Doheny Eye Center UCLA — Pasadena
• University of California, Davis — Sacramento
• University of California, San Francisco — San Francisco
• Mile High Eye Institute — Sheridan
• Clear Vue Laser Eye Center — Lakeworth
• Northwestern Medical Group — Chicago
• Chicago Arbor Eye Institute — Orland Park
• … и ещё 20 центров

Канада · 1 центр

• Ocular Health Centre — Kitchener

Публикации

• Realini T, Gazzard G, Latina M, Kass M. Low-energy Selective Laser Trabeculoplasty Repeated Annually: Rationale for the COAST Trial. J Glaucoma. 2021 Jul 1;30(7):545-551. doi: 10.1097/IJG.0000000000001788. PMID 33428350

Идентификаторы

NCT: NCT04967989 · STUDY21060171 · UG1EY031651 · UG1EY031654 · STUDY21080018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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