Keratometric Change After XEN, Trabeculectomy and Tube Shunts

NCT04602923 | Completed

• 1 other identifier: 20.240
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Glaucoma drainage devices; Xen Gel Stent; Baerveldt glaucoma implant; Ahmed glaucoma implant; Trabeculectomy

Outcome Measures

Primary Outcomes (2)

• Keratometric values (OPD-Scan)

  Change in simulated keratometric (K) values obtained by OPD-Scan between the indicated timepoints.

  Baseline, 2 months, 6 months, 12 months

• Keratometric values (Pentacam)

  Change in simulated keratometric (K) values obtained by Pentacam between the indicated timepoints.

  Baseline, 2 months, 6 months, 12 months

Secondary Outcomes (5)

• Best-corrected visual acuity change

  Baseline, 2 months, 6 months, 12 months

• Intraocular pressure change

  Baseline, 2 months, 6 months, 12 months

• Visual field change change

  Baseline, 6 months, 12 months

• Retinal nerve fiber layer thickness change

  Baseline, 6 months, 12 months

• Ganglion cell layer thickness change

  Baseline, 6 months, 12 months

Study Arms (3)

XEN Gel Stent implantation

EXPERIMENTAL

Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation

Diagnostic Test: Corneal topography: OPD-Scan; Diagnostic Test: Corneal topography: Pentacam

Trabeculectomy

EXPERIMENTAL

Participants suffering from glaucoma who are candidates for trabeculectomy

Diagnostic Test: Corneal topography: OPD-Scan; Diagnostic Test: Corneal topography: Pentacam

GDD implantation

EXPERIMENTAL

Participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)

Diagnostic Test: Corneal topography: OPD-Scan; Diagnostic Test: Corneal topography: Pentacam

Interventions

Corneal topography: OPD-Scan DIAGNOSTIC_TEST

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

GDD implantation; Trabeculectomy; XEN Gel Stent implantation

Corneal topography: Pentacam DIAGNOSTIC_TEST

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

GDD implantation; Trabeculectomy; XEN Gel Stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients less than 18 years old;
• Inability to provide informed consent;
• Inability to be followed for the entire duration of the study;
• Patients undergoing surgery combined with cataract extraction;
• Presence of severe dry eye disease;
• Presence of ocular comorbidities other than glaucoma, such as corneal or retinal disease.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Allergan: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (9)

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

  PMID: 16488940 BACKGROUND

• Banitt M. Evaluation and management of glaucoma after keratoprosthesis. Curr Opin Ophthalmol. 2011 Mar;22(2):133-6. doi: 10.1097/ICU.0b013e328343723d.

  PMID: 21191292 BACKGROUND

• Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104. doi: 10.1097/ICU.0b013e32834ff1e7.

  PMID: 22249233 BACKGROUND

• Lavia C, Dallorto L, Maule M, Ceccarelli M, Fea AM. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis. PLoS One. 2017 Aug 29;12(8):e0183142. doi: 10.1371/journal.pone.0183142. eCollection 2017.

  PMID: 28850575 BACKGROUND

• Chatzara A, Chronopoulou I, Theodossiadis G, Theodossiadis P, Chatziralli I. XEN Implant for Glaucoma Treatment: A Review of the Literature. Semin Ophthalmol. 2019;34(2):93-97. doi: 10.1080/08820538.2019.1581820. Epub 2019 Feb 21.

  PMID: 30789072 BACKGROUND

• Chan HHL, Kong YXG. Glaucoma surgery and induced astigmatism: a systematic review. Eye Vis (Lond). 2017 Nov 17;4:27. doi: 10.1186/s40662-017-0090-x. eCollection 2017.

  PMID: 29177182 BACKGROUND

• Pakravan M, Alvani A, Esfandiari H, Ghahari E, Yaseri M. Post-trabeculectomy ocular biometric changes. Clin Exp Optom. 2017 Mar;100(2):128-132. doi: 10.1111/cxo.12477. Epub 2016 Sep 29.

  PMID: 27686794 BACKGROUND

• Koivusalo R, Valimaki J. Effect of glaucoma drainage implant surgery on corneal topography: a prospective study. Acta Ophthalmol. 2020 May;98(3):305-309. doi: 10.1111/aos.14247. Epub 2019 Sep 8.

  PMID: 31495070 BACKGROUND

• Miraftabi A, Lotfi M, Nilforushan N, Abdolalizadeh P, Jafari S. Ocular biometric changes after Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2021 Jan;31(1):120-124. doi: 10.1177/1120672119889528. Epub 2019 Nov 21.

  PMID: 31752527 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Georges Durr, MD, FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups will be compared: * Group 1: 30 participants suffering from glaucoma who are candidates for XEN Gel Stent implantation * Group 2: 30 participants suffering from glaucoma who are candidates for trabeculectomy * Group 3: 30 participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: November 4, 2020
• Primary Completion: April 1, 2024
• Study Completion: August 7, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)