Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Официальное название

Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)

Обзор

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Вмешательства

• Устройство Ab-interno canaloplasty utilizing the iTrack Advance device
  360 degree microcatheterization and viscodilation of Schlemm's canal
• Устройство Ab-interno canaloplasty utilizing the OMNI Surgical System
  360 degree microcatheterization and viscodilation of Schlemm's canal

Первичные конечные точки

• The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline [Срок оценки: 12 months]
• Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline and without any other intervention (medication or secondary surgery) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Male or female subjects, 22 years or older at the time of surgery
• Diagnosed with mild to moderate primary open angle glaucoma
• Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy
• Intolerance to medical therapy OR need/willingness to reduce medications
• At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications
• At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 36 mmHg, and ≥ 3mmHg higher than medicated IOP
• Shaffer grade of ≥ 3 in all four quadrants
• Central corneal thickness ≥ 480µm and ≤ 620 µm
• Able and willing to comply with the study procedures and attend all follow-up visits
• Understands and signs the informed consent

Критерии исключения

• Any of the following prior treatments for glaucoma (study eye):

• Laser trabeculoplasty

i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty

• iStent or iStent Inject within 180 days of the Screening Visit
• Endocyclophotocoagulation (ECP) or Micropulse laser
• Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
• Prior canaloplasty (ab interno and ab externo)
• Prior goniotomy, or trabeculotomy (ab externo and ab interno)
• Hydrus microstent
• Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
• Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.)
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma
• Cataract surgery within 6 months of the Screening Visit in the study eye
• History of fellow eye with cataract surgery within 30 days of Screening
• Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 36 mmHg
• Use of systemic medications (either current, within 30 calendar days of Screening exam, or anticipated) that may cause an increase in IOP, (e.g., systemic steroids including inhaled and oral steroids used on a regular basis)
• Ocular and/or systemic diseases that could affect the corneal endothelium (such as corneal endothelial dystrophy, intraocular inflammation and infection, or congenital abnormalities)
• History of penetrating keratoplasty or another corneal transplant
• BCVA of 20/200 or worse in the fellow eye not due to cataract
• Previous treatment with OMNI or iTrack (Note: permitted if fellow eye only was treated)
• BCVA of 20/50 or worse in the study eye not due to posterior capsular opacification

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

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 3 центра

• Princess Alexandra Eye Pavilion, NHS Lothian — Edinburgh
• St. Paul's Eye Unit, Liverpool University — Liverpool
• Manchester Royal Eye Hospital — Manchester

Германия · 1 центр

• Breyer Kaymak Klabe Augenchirurgie — Düsseldorf

Испания · 1 центр

• Hospital Clinico San Carlos, Servicio de Oftalmologia — Madrid

Идентификаторы

NCT: NCT05786196 · NE 05021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗