NCT06680245Not yet recruitingPhase 3
Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are: Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases? Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications. Participants will: * Undergo baseline assessment including eye examination and measurement of intraocular pressure. * Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery. * Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 27 May 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Diseases
- Glaucoma
- NCT number
- NCT06680245
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 144
- From 1 Dec 2024 to the primary completion date, 1 Jul 2026
- No sites listed in no 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
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Treatment or plan to treat with topical or systemic steroids
- Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
Other illness
- Corneal disease affecting visualization of anterior chamber of the eye
- Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.
Other
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
Who the study is looking for
- Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP \> 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.