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Keratometric Change After XEN, Trabeculectomy and Tube Shunts (Topo-XEN)

Primary Purpose

Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma Secondary

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Corneal topography: OPD-Scan
Corneal topography: Pentacam
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Glaucoma drainage devices, Xen Gel Stent, Baerveldt glaucoma implant, Ahmed glaucoma implant, Trabeculectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

XEN Gel Stent implantation

Trabeculectomy

GDD implantation

Arm Description

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

Participants suffering from glaucoma who are candidates for trabeculectomy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best-corrected visual acuity change
Evaluation of visual acuity change, measured using the Snellen chart.
Intraocular pressure change
Evaluation of intraocular pressure control, measured using gold standard Goldmann applanation tonometry.
Visual field change change
Evaluation of visual field change. Visual field change will be calculated using the mean deviation (MD) values and pattern standard deviation (PSD) values measured using automated Humphrey 24-2 perimetry.
Retinal nerve fiber layer thickness change
Evaluation of retinal nerve fiber layer (RNFL) thickness change (µm), using the average RNFL thickness values measured using Spectral Domain Optical Coherence Tomography (SD-OCT). The change in thickness (µm) will be calculated between the time points described.
Ganglion cell layer thickness change
Evaluation of ganglion cell layer (GCL+) thickness. This GCL+ thickness is measured using the values for the average ganglion cell layer and inner plexiform layer thickness of the retina (value called "Average GCL + IPL thickness") obtained by Spectral Domain Optical Coherence Tomography (SD-OCT). The change in thickness (µm) will be calculated between the time points described.

Full Information

First Posted
October 21, 2020
Last Updated
February 14, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04602923
Brief Title
Keratometric Change After XEN, Trabeculectomy and Tube Shunts
Acronym
Topo-XEN
Official Title
Comparison of Keratometric Change After Xen Gel Stent Implantation, Trabeculectomy, and Tube Shunts
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Following glaucoma surgery, patients often experience decreased visual acuity (VA) which can partly be explained by induced changes to the optical properties of the cornea. Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all meridians. Obtained keratometric measures (termed K values) can allow clinicians to quantify the amount of astigmatism before and after surgical intervention. Multiple studies have been previously published to evaluate induced postoperative astigmatism after trabeculectomy. However, only two studies have characterized the impact of GDDs on keratometric values. To the best of our knowledge, no study has yet attempted to quantify the amount of astigmatism induced by the XEN Gel Stent. Assessing the impact of the XEN implant on corneal astigmatism is important to better characterize the expected course of postoperative visual rehabilitation, the impact of novel glaucoma devices on corneal properties and the predictability of refractive outcomes after XEN implantation. Compared to traditional filtering surgery, the XEN Gel Stent is inserted without opening the conjunctiva and is implanted further from the corneal limbus (5 mm). These factors may allow for a reduced amount of surgically induced corneal astigmatism. We hypothesize that the XEN Gel Stent implantation induces less corneal astigmatism compared to traditional filtering surgery, such as the trabeculectomy and GDDs (BGI or AGV). The main goal of this prospective interventional comparative 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). Secondary objectives are evaluation of visual acuity recovery as well as IOP reduction and other parameters between groups. Glaucoma surgery (XEN Gel Stent, trabeculectomy or GDD implantation) will be performed by the ophthalmologists in charge of the study according to standard procedures. For each patient, the most appropriate type of glaucoma surgery will be recommended by the ophthalmologist regardless of patients' participation in the study, as dictated by the specific nature of their glaucoma and following current standards of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma Secondary, Glaucoma Eye
Keywords
Glaucoma drainage devices, Xen Gel Stent, Baerveldt glaucoma implant, Ahmed glaucoma implant, Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XEN Gel Stent implantation
Arm Type
Experimental
Arm Description
Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation
Arm Title
Trabeculectomy
Arm Type
Experimental
Arm Description
Participants suffering from glaucoma who are candidates for trabeculectomy
Arm Title
GDD implantation
Arm Type
Experimental
Arm Description
Participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)
Intervention Type
Diagnostic Test
Intervention Name(s)
Corneal topography: OPD-Scan
Intervention Description
Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography.
Intervention Type
Diagnostic Test
Intervention Name(s)
Corneal topography: Pentacam
Intervention Description
Corneal topography photography, taken by Scheimpflug imaging (Pentacam) by measuring corneal curvature, thickness and topography.
Primary Outcome Measure Information:
Title
Keratometric values (OPD-Scan)
Description
Change in simulated keratometric (K) values obtained by OPD-Scan between the indicated timepoints.
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Keratometric values (Pentacam)
Description
Change in simulated keratometric (K) values obtained by Pentacam between the indicated timepoints.
Time Frame
Baseline, 2 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity change
Description
Evaluation of visual acuity change, measured using the Snellen chart.
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Intraocular pressure change
Description
Evaluation of intraocular pressure control, measured using gold standard Goldmann applanation tonometry.
Time Frame
Baseline, 2 months, 6 months, 12 months
Title
Visual field change change
Description
Evaluation of visual field change. Visual field change will be calculated using the mean deviation (MD) values and pattern standard deviation (PSD) values measured using automated Humphrey 24-2 perimetry.
Time Frame
Baseline, 6 months, 12 months
Title
Retinal nerve fiber layer thickness change
Description
Evaluation of retinal nerve fiber layer (RNFL) thickness change (µm), using the average RNFL thickness values measured using Spectral Domain Optical Coherence Tomography (SD-OCT). The change in thickness (µm) will be calculated between the time points described.
Time Frame
Baseline, 6 months, 12 months
Title
Ganglion cell layer thickness change
Description
Evaluation of ganglion cell layer (GCL+) thickness. This GCL+ thickness is measured using the values for the average ganglion cell layer and inner plexiform layer thickness of the retina (value called "Average GCL + IPL thickness") obtained by Spectral Domain Optical Coherence Tomography (SD-OCT). The change in thickness (µm) will be calculated between the time points described.
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Catherine Tessier, MSc
Phone
1-514-890-8000
Ext
11550
Email
marie-catherine.tessier.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Geoffrion, BSc
Phone
1-514-890-8000
Ext
11550
Email
dominique.geoffrion@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Durr, MD, FRCSC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Catherine Tessier, MSc
Phone
1-514-890-8000
Ext
11550
Email
marie-catherine.tessier.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Georges Durr, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Younes Agoumi, MD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16488940
Citation
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.
Results Reference
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PubMed Identifier
21191292
Citation
Banitt M. Evaluation and management of glaucoma after keratoprosthesis. Curr Opin Ophthalmol. 2011 Mar;22(2):133-6. doi: 10.1097/ICU.0b013e328343723d.
Results Reference
background
PubMed Identifier
22249233
Citation
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.
Results Reference
background
PubMed Identifier
28850575
Citation
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.
Results Reference
background
PubMed Identifier
30789072
Citation
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.
Results Reference
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PubMed Identifier
29177182
Citation
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.
Results Reference
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PubMed Identifier
27686794
Citation
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.
Results Reference
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PubMed Identifier
31495070
Citation
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.
Results Reference
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PubMed Identifier
31752527
Citation
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.
Results Reference
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Keratometric Change After XEN, Trabeculectomy and Tube Shunts

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