MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- ocular surface disease index score
研究概览
简要总结
MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.
详细描述
This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
- •Poor therapeutic adherence
- •Local or general intolerance to topical treatments.
排除标准
- •Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
- •Pevious transscleral laser therapy applied to the same eye
- •angle-closure glaucoma
- •active ocular inflammation
- •a non-functional eye (absence of light perception)
- •scleral thinning
结局指标
主要结局
ocular surface disease index score
时间窗: 6 months
This score is calculated and ranges from 0 to 100 with the following interpretation: * 0 to 12 = Normal * 13 to 22 = Mild ocular surface disease * 23 to 32 = Moderate ocular surface disease * 33 to 100 = Severe ocular surface disease
conjunctival inflammation or fibrosis
时间窗: 1 month
histological changes of the conjunctiva according to a scale ranging from 0 to 3, with the following interpretation: * Grade 0: no difference between the two samples * Grade 1: increase in inflammation / fibrosis \< 33% * Grade 2: increase in inflammation / fibrosis from 33% to 66% * Grade 3: increase in inflammation / fibrosis \> 66%
intraocular pression
时间窗: 6 months
change in intraocular pression
次要结局
未报告次要终点
研究者
Walid Zbiba
Professor
University Tunis El Manar