In Vivo Imaging and Impression Cytology Analysis of Conjunctival Changes as Potential Indicators for Ab-interno Gelatin Microstent Implantation Surgery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- In vivo confocal microscopy of the filtering bleb
研究概览
简要总结
Trabeculectomy and XEN45 gel stent implantation are glaucoma surgeries that creates an aqueous humor (AH) shunt towards the subconjunctival space (filtration bleb). Once the AH reaches the subconjunctival space, it is removed by different paths such as the trans-bleb wall route. For this reason, the conjunctiva is considered an essential structure that may condition the glaucoma filtering procedures outcomes. As part of the inflammatory response, an unbalanced fibrosis during the postoperative period may lead to a bleb cavity scarring and failure; for this reason, bleb massage and antifibrotic injections (i.e., 5-Fluoruracil) are frequently required as part of the postoperative care of these procedures. There have been described several risk factors, such as intraocular pressure (IOP) lowering medications, previous surgical interventions or ocular surface disease that may predispose to an early failure. These preoperative factors fail to aim to predict the surgical outcomes.
However, ocular biomarkers may overcome this limitation. There are promising studies that have analyzed the role of in vivo confocal microscopy (IVCM), anterior-segment optical coherence tomography (AS-OCT) and conjunctival cytology impression as clinical tools that may improve the filtration bleb assessment at a cellular level.
详细描述
Detailed description Hypothesis
- Conjunctival biomarkers may represent a predictive factor to determine the XEN45 and trabeculectomy surgical success and outcomes
- A cellular-based analysis may help to predict postoperative pro-fibrotic changes that may lead to an early or mid-term surgery failure, and therefore it could help to improve the postoperative care of the filtering bleb.
Objective
- To evaluate the preoperative and postoperative conjunctival factors that may influence in the surgical outcomes of XEN45 gel stent compared to trabeculectomy using in vivo confocal microscopy, anterior segment optical coherence tomography and conjunctival cytology impression
- To assess the efficacy of XEN Gel stent and trabeculectomy to predict IOP, based on the morphologic characteristics of the filtering bleb
- To analyze the needling rate during the postoperative bleb management and the potential correlation to the pre and postoperative conjunctival changes and surgical success outcomes
Design Single-center, prospective, simple-blind study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary open angle glaucoma
- •Written informed consent
- •Older than 18 years old
排除标准
- •Patients that don't fully understand the purpose and the postoperative care
- •Severe or end-stage glaucoma
- •Patients with prior ocular surgery, excluding uncomplicated phacoemulsification 6 months prior to the inclusion in the study
结局指标
主要结局
In vivo confocal microscopy of the filtering bleb
时间窗: Preoperative to 6 months operative
Increase of the mean microcysts density (MMD): number of cysts/mm2
Conjunctival impression cytology of the filtering bleb
时间窗: Preoperative to 6 months operative
Increase in the percentage of goblet cells biomarkers
Anterior segment optical coherence tomography microscopy of the filtering bleb
时间窗: Preoperative to 6 months operative
Differences in thickness of the conjunctival epithelial surface and the bleb wall, in micrometers
次要结局
- Intraocular pressure(Preoperative to 6 months visit, at each follow-up visit)
- Glaucoma medications(Preoperative to 6 months visit, at each follow-up visit)
研究者
Néstor Ventura
Investigator, Glaucoma Department
Hospital Clinic of Barcelona
