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Keratometric Change After XEN, Trabeculectomy and Tube Shunts

NCT04602923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-09

No results posted yet for this study

Summary

The main goal of this study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surgery (trabeculectomy and GDDs). Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all meridians. To the best of our knowledge, no study has yet attempted to quantify the amount of astigmatism induced by the XEN Gel Stent.

Conditions

  • Glaucoma, Open-Angle
  • Glaucoma, Angle-Closure
  • Glaucoma Secondary
  • Glaucoma Eye

Interventions

DIAGNOSTIC_TEST

Corneal topography: OPD-Scan

Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography.

DIAGNOSTIC_TEST

Corneal topography: Pentacam

Corneal topography photography, taken by Scheimpflug imaging (Pentacam) by measuring corneal curvature, thickness and topography.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Georges Durr, MD, FRCSC · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2024-04-01
Completion
2024-08-07

Countries

  • Canada

Study Locations

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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 NCT04602923 on ClinicalTrials.gov