Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery

Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
• Previous incisional glaucoma surgery
• Incisional glaucoma surgery scheduled within 1 year of intervention
• Corneal disease affecting visualization of anterior chamber of the eye
• Treatment or plan to treat with topical or systemic steroids
• Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
• Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.