Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery

Обзор

The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are: Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases? Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications. Participants will: * Undergo baseline assessment including eye examination and measurement of intraocular pressure. * Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery. * Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.

Вмешательства

• Препарат Mitomycin c
  Patients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced g

Первичные конечные точки

• Change in Intraocular Pressure assessed using the Goldmann applanation tonometer [Срок оценки: Baseline to 1-year follow-up visit]

Вторичные конечные точки (4)

• Number of Glaucoma Medications assessed by reviewing of patient medication records [Срок оценки: Baseline to 1-year follow-up visit]
• Visual Acuity assessed using the Snellen chart. [Срок оценки: Baseline to 1-year follow-up visit]
• Anterior Chamber Inflammation assessed using the Slit-lamp examination [Срок оценки: Baseline to 1-year follow-up visit]
• Progression to Surgical Therapy measured using clinical evaluation and surgical records. [Срок оценки: Baseline to 1-year follow-up visit]

Критерии участия

Критерии включения

• Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
• Participant must be over 18 years of age
• IOP > 16mmHg on at least two consecutive occasions separated by one month
• Two sighted eyes with visual acuity of 20/200 or better
• Informed consent from patient

Критерии исключения

• Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
• Previous incisional glaucoma surgery
• Incisional glaucoma surgery scheduled within 1 year of intervention
• Corneal disease affecting visualization of anterior chamber of the eye
• Treatment or plan to treat with topical or systemic steroids
• Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
• Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192. PMID 24825645
• Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30. PMID 21453963
• Margolis KL, Rich EC. Open-angle glaucoma. Prim Care. 1989 Mar;16(1):197-209. PMID 2649902
• Sharts-Hopko NC, Glynn-Milley C. Primary open-angle glaucoma. Am J Nurs. 2009 Feb;109(2):40-7; quiz 48. doi: 10.1097/01.NAJ.0000345434.37734.ee. PMID 19299999
• Alasbali T, Alghamdi AA, Khandekar R. Outcomes of Ahmed valve surgery for refractory glaucoma in Dhahran, Saudi Arabia. Int J Ophthalmol. 2015 Jun 18;8(3):560-4. doi: 10.3980/j.issn.2222-3959.2015.03.22. eCollection 2015. PMID 26086008
• Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268. PMID 12365904
• Riva I, Roberti G, Oddone F, Konstas AG, Quaranta L. Ahmed glaucoma valve implant: surgical technique and complications. Clin Ophthalmol. 2017 Feb 17;11:357-367. doi: 10.2147/OPTH.S104220. eCollection 2017. PMID 28255226
• Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozertrk Y. The effect of adjunctive mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan - Feb 2005;15(1):27-31. doi: 10.5301/EJO.2008.210. PMID 28221428

Идентификаторы

NCT: NCT06680245 · 16370

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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