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Идёт набор NCT05331664

Dropless Pars Plana Vitrectomy Study

Фаза IV С лечением Rhegmatogenous Retinal Detachment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL, Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin, Prednisolone 1%.
Кому может быть актуально
Состояния в реестре: Rhegmatogenous Retinal Detachment. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.

Подробное описание

This is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. Investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. Patients will be randomized to one of the following groups:

* Group 1: A total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week. * Group 2: A total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/mL) at the time of surgery, with no post-operative eye drops.

Both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery.

Вмешательства

  • Процедура Pars plana vitrectomy
    Standard of care surgery
  • Препарат Triamcinolone Acetonide 40mg/mL
    Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
  • Препарат Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
    Antibiotic eye drop 4 times per day for 1 week after surgery
  • Препарат Prednisolone 1%
    Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
  • Препарат Atropine 1%
    Eye drop daily for 1 week after surgery

Первичные конечные точки

  • Mean anterior chamber cell [Срок оценки: Day 7 after surgical procedure]
Вторичные конечные точки (10)
  • Mean anterior chamber cell [Срок оценки: Day 1, 30 and 90 after surgical procedure]
  • Need for rescue medication (corticosteroid) [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]
  • Intraocular pressure less than 5 or more 30 mmHg [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]
  • Need for medications to reduce intraocular pressure [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]
  • Visual acuity [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]
  • Degree of pain [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]
  • Self-reported adherence to positioning [Срок оценки: Day 1 and 7 after surgical procedure]
  • Self-reported adherence to eye drops [Срок оценки: Day 1, 7 and 30 after surgical procedure]
  • Progression of cataract [Срок оценки: Day 30 and 90 after surgical procedure]
  • Adverse events [Срок оценки: Day 1, 7, 30 and 90 after surgical procedure]

Критерии участия

Критерии включения

  • Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

Критерии исключения

  • Need for concomitant lensectomy or cataract surgery
  • Pars plana vitrectomy taking place more than seven days after the initial diagnosis
  • History of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye
  • History of previous retinal detachment in surgical eye
  • History of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye
  • History of ocular laser surgery within 1 month in surgical eye
  • History of intravitreal injection within 1 month in surgical eye
  • Diagnosis of glaucoma or intraocular pressure more than 21 mmHg in either eye
  • Active or chronic or recurrent uncontrolled ocular or systemic disease
  • Active or history of chronic or recurrent inflammatory eye disease
  • Previous history of steroid response
  • Current treatment with oral, topical, or intravitreal corticosteroids
  • Presence of proliferative vitreoretinopathy at the time of diagnosis
  • Presence of giant retinal tear at the time of diagnosis
  • Diagnosis of proliferative diabetic retinopathy
  • Anterior chamber inflammation on presentation in either eye
  • Signs of ocular infection at presentation in either eye
  • Acute external ocular infections
  • Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
  • Inability to use or apply topical eye drops
  • Requirement for silicone oil as a tamponade agent
  • Individuals with impaired decision-making capacity
  • Non-English-speaking subjects

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Massachusetts Eye and Ear — Boston

Публикации

  • Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24. PMID 17459031
  • Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1. PMID 34766851
  • Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556. PMID 32455658
  • Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708. PMID 33273209

Идентификаторы

NCT: NCT05331664 · 2022P000046

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗