A Prospective, Single Surgeon, Randomized Control Study Comparing ab Interno XEN Gel Microstent I… (NCT04943185) | Clinical Trial Compass
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A Prospective, Single Surgeon, Randomized Control Study Comparing ab Interno XEN Gel Microstent Implantation vs Closed Conjunctiva ab Externo Implantation Performed at the Slit Lamp for the Treatment of Uncontrolled Glaucoma
Canada50 participantsStarted 2021-08-01
Plain-language summary
The objective of the study is to prospectively compare the success rate of ab externo implantation and outcome measures of glaucoma filtering surgery namely IOP (intraocular pressure), number of glaucoma medications, adjunct procedure and adverse events rate compared to the traditional ab interno implantation technique.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Male or female who was in good general health and \>18 years of age at the time of the preoperative exam
✓. The subject complied with post-operative instructions and made their scheduled office appointments
Exclusion criteria
✕. Known or suspected allergy or sensitivity to any medications/diagnostic agents (eg, topical anesthetic, dilating drops, fluorescein) required for this protocol or any of the XEN components (eg, porcine products or glutaraldehyde)
✕. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator) or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day)
✕. Chemotherapy for cancer treatment within 6 months of screening
✕. History of dermatologic keloid formation
✕. Participation in another drug/device/observational clinical trial concurrently or concluding within 30 days of screening
✕. Any condition that would preclude the patient's ability to comply with study requirements, including completion of the study
✕. Any condition or a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study Ocular
What they're measuring
1
Compared the success of interno / externo implantation
. Close-angle glaucoma (previous iridotomy laser accepted) active acute angle closure attack, secondary glaucomas (eg, anterior subluxation of the lens, iris or ciliary body cysts, active iris and angle neovascularization, iridocorneal endothelial syndrome,) in the study eye