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Analysis of Conjunctival Changes as Indicators for Ab-interno Gelatin Microstent Implantation Surgery Outcomes

NCT04727411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-01-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

XEN45 Gel stent

XEN Gel stent implantation either combined or as a stand-alone procedure

PROCEDURE

Trabeculectomy

XEN Gel stent implantation either combined or as a stand-alone procedure

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Marta Pazos, MD, PhD · Hospital Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-05-31
Completion
2022-10-17

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727411 on ClinicalTrials.gov