跳至主要内容
临床试验/NCT04352660
NCT04352660已完成4 期

Subconjunctival Versus Direct Scleral Application of Mitomycin-C in Trabeculectomy

University of California, San Diego0 个研究点目标入组 100 人开始时间: 2016年5月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
主要终点
Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds

研究概览

简要总结

Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.

详细描述

Trabeculectomy is widely used as a surgical treatment of uncontrolled open glaucoma. Success of trabeculectomy at halting or slowing glaucoma progression primarily relies on the extent of conjunctival and sclera wound healing. The success rates of trabeculectomy increased dramatically with the introduction of anti-metabolites. For more than two decades mitomycin-c (MMC), a chemotherapeutic agent capable of decreasing fibroblast activity and modulating wound healing at the bleb, has been used with trabeculectomy. The complications of MMC are well known and several studies have described various methods of application based on exposure time, dose and surface area. Numerous retrospective and prospective studies have compared the efficacy of MMC applied beneath the conjunctival flap with soaked sponges versus intrascleral application. In 2008, Lee et al. first described an alternative route of application: subconjunctival injection of MMC directly into the intra-Tenon area. Seventy-six eyes with primary and secondary open angle glaucoma underwent trabeculectomy with this approach and were followed for one year post-operatively. Eighty-six percent of eyes achieved an IOP <21 mm Hg and 57% an IOP<14 mm Hg at one year without adjunctive drops. Transient complications included hyphema, bleb leak and choroidal detachment. The advantages of injected MMC are primarily in controlling the exact dosage and area of application and reduced surgical time. Lim et al. retrospectively reviewed the outcomes of trabeculectomy in 57 eyes using sponge application directly to the sclera versus intra-tenon injection. IOP was significantly lower in the injection group at 1 month, 1, 2, and 3 years. Trabeculectomy success (IOP<21mm Hg or IOP >20% below baseline without medications or additional surgery) was greater in the injection group at 3 years. The sponge group experienced more encapsulated blebs but complication rates were similar in both groups. To date, there have been no prospective studies comparing the IOP-lowering efficacy and safety of intra-tenon injection versus direct scleral application of MMC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • medically uncontrolled glaucoma
  • healthy and freely mobile conjunctiva in superior bulbar region

排除标准

  • previous incisional glaucoma surgery
  • no light perception vision
  • pregnant or nursing women
  • iris neovascularization or proliferative retinopathy
  • iridocorneal endothelial syndrome
  • chronic or recurrent uveitis
  • steroid-induced glaucoma
  • pathologic myopia or refractive error less than -6.00 diopters
  • unwillingness or inability to give consent
  • inability to return for scheduled protocol visits

研究组 & 干预措施

Injection group

Active Comparator

MMC delivered by preoperative subconjunctival injection

干预措施: Mitomycin-C injection (Drug)

Sponge group

Active Comparator

MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges

干预措施: Mitomycin-C sponge (Drug)

结局指标

主要结局

Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds

时间窗: 6 months

Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."

次要结局

  • Visual Acuity(6 months)
  • Bleb Morphology(6 months)
  • Number of Participants With Surgical Complications(6 months)
  • Medications(6 months)
  • Number of Participants Requiring Additional Surgery(6 months)
  • Postoperative Interventions(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiun Do

Assistant Professor

University of California, San Diego

相似试验