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NCT Number: NCT06680245

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mitomycin C

Drug

Patients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced glaucoma specialist performs the surgery, injecting 0.2 mg/ml mitomycin-C into the sclera for the experimental group, while the control group receives no intervention. The area is irrigated with 40mL balanced salt solution before implant insertion. Post-operative care includes topical antibiotics and steroids for six weeks, with follow-ups at 1 and 2 weeks, and 1, 3, 6, and 12 months to monitor visual acuity, IOP, anterior chamber reaction, complications, and additional glaucoma medications.

Primary outcomes

  1. Change in Intraocular Pressure assessed using the Goldmann applanation tonometer

    Time frame: Baseline to 1-year follow-up visit

    The percentage decrease in intraocular pressure (IOP) from baseline will be calculated and compared between the two groups from baseline to 1-year follow-up. It will be measured using the Goldmann applanation tonometer and performed at approximately the same time of the day to account for diurnal variation. Two measurements will be averaged if the difference is less or equal to 2mmHg. If the difference is greater than 2mmHg, then three measurements will be taken and the median will be recorded. The baseline IOP will be the average of three different IOP values taken at different times of the day on at least two separate days within a period of a month. In this study, the baseline IOP will be the average IOP of previous IOP measurement and the day of surgery.

Secondary outcomes

  1. Number of Glaucoma Medications assessed by reviewing of patient medication records

    Time frame: Baseline to 1-year follow-up visit

    Changes in the number of glaucoma medications need per patient in each group will be compared using observations and by reviewing patient medication records from baseline to 1-year follow-up. This outcome will assess whether the intervention affects the number of prescribed glaucoma medications for the patients.

  2. Visual Acuity assessed using the Snellen chart.

    Time frame: Baseline to 1-year follow-up visit

    Changes in visual acuity from baseline to 1-year follow-up will be measured using the Snellen chart. This outcome will assess whether the intervention affects the overall visual function of the patients.

  3. Anterior Chamber Inflammation assessed using the Slit-lamp examination

    Time frame: Baseline to 1-year follow-up visit

    The anterior chamber inflammation at every post-operative visit will be compared to assess any complications during the surgery. This will be measured using the slit-lamp examination.

  4. Progression to Surgical Therapy measured using clinical evaluation and surgical records.

    Time frame: Baseline to 1-year follow-up visit

    The progression to surgical therapy in each group will be compared from baseline to 1-year follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharan Bains

CONTACT

[email protected]

905-522-1155 ext. 38505

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Acronym: MMC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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