Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
NCT Number: NCT04602923
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 3E4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography.
Corneal topography photography, taken by Scheimpflug imaging (Pentacam) by measuring corneal curvature, thickness and topography.
Time frame: Baseline, 2 months, 6 months, 12 months
Change in simulated keratometric (K) values obtained by OPD-Scan between the indicated timepoints.
Time frame: Baseline, 2 months, 6 months, 12 months
Change in simulated keratometric (K) values obtained by Pentacam between the indicated timepoints.
Time frame: Baseline, 2 months, 6 months, 12 months
Evaluation of visual acuity change, measured using the Snellen chart.
Time frame: Baseline, 2 months, 6 months, 12 months
Evaluation of intraocular pressure control, measured using gold standard Goldmann applanation tonometry.
Time frame: Baseline, 6 months, 12 months
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
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
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.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Comparison of Keratometric Change After Xen Gel Stent Implantation, Trabeculectomy, and Tube Shunts
Acronym: Topo-XEN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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