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NCT04602923Completed

Keratometric Change After XEN, Trabeculectomy and Tube Shunts

Comparison of Keratometric Change After Xen Gel Stent Implantation, Trabeculectomy, and Tube Shunts

Source: ClinicalTrials.gov · Last updated 9 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
21 Oct 2020
Start date
4 Nov 2020
Primary completion date
1 Apr 2024
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Diseases
Glaucoma
NCT number
NCT04602923

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 4 Nov 2020 to the primary completion date, 1 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients undergoing surgery combined with cataract extraction;

Other illness

  • Presence of severe dry eye disease;
  • Presence of ocular comorbidities other than glaucoma, such as corneal or retinal disease.

Age

  • Patients less than 18 years old;

Other

  • Inability to provide informed consent;
  • Inability to be followed for the entire duration of the study;

Who the study is looking for

  • Eyes with an IOP above target and/or progressing on maximally tolerated medical therapy;
  • Patients aged 18 years or older;
  • Ability to provide informed consent;
  • Ability to be followed for the entire duration of the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier de l'Universite de Montreal (CHUM)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.