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

NCT06680245 | Not Yet Recruiting Phase 3

• 1 other identifier: 16370
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glaucoma

Keywords

Refractory Glaucoma; Intraocular Pressure; Ahmed Glaucoma Valve; Mitomycin-C; Glaucoma Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure assessed using the Goldmann applanation tonometer

  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.

  Baseline to 1-year follow-up visit

Secondary Outcomes (4)

• Number of Glaucoma Medications assessed by reviewing of patient medication records

  Baseline to 1-year follow-up visit

• Visual Acuity assessed using the Snellen chart.

  Baseline to 1-year follow-up visit

• Anterior Chamber Inflammation assessed using the Slit-lamp examination

  Baseline to 1-year follow-up visit

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

  Baseline to 1-year follow-up visit

Study Arms (2)

Mitomycin-C Treatment

EXPERIMENTAL

The intervention aims to assess the efficacy of Mitomycin-C in preventing postoperative hypertensive phases by inhibiting fibroblast proliferation around the surgical site. Patients in this arm will receive a 0.2 mg/mL Mitomycin-C injection into the sclera during Ahmed Glaucoma Valve implantation surgery. The total volume of the injection will be 1 mL, administered once intraoperatively.

Drug: Mitomycin c

Control

NO INTERVENTION

Patients in this arm will undergo the Ahmed Glaucoma Valve implantation surgery without the addition of Mitomycin-C. This group serves as a control to evaluate the effects of the Ahmed Valve alone in managing intraocular pressure in patients with refractory glaucoma. Postoperative care remains consistent with the experimental group, involving the same regimen of topical antibiotics and steroids.

Interventions

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.

Mitomycin-C Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Related Publications (18)

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• Riva I, Roberti G, Oddone F, Konstas AG, Quaranta L. Ahmed glaucoma valve implant: surgical technique and complications. Clin Ophthalmol. 2017 Feb 17;11:357-367. doi: 10.2147/OPTH.S104220. eCollection 2017.

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• Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozertrk Y. The effect of adjunctive mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan - Feb 2005;15(1):27-31. doi: 10.5301/EJO.2008.210.

  PMID: 28221428 BACKGROUND

• Luzu J, Baudouin C, Hamard P. The role of Ahmed glaucoma valve in the management of refractory glaucoma: Long-term outcomes and complications. Eur J Ophthalmol. 2021 Sep;31(5):2383-2389. doi: 10.1177/1120672120968733. Epub 2020 Nov 25.

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• Cui QN, Hsia YC, Lin SC, Stamper RL, Rose-Nussbaumer J, Mehta N, Porco TC, Naseri A, Han Y. Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation. Clin Exp Ophthalmol. 2017 Mar;45(2):128-134. doi: 10.1111/ceo.12811. Epub 2016 Sep 1.

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• Tien M., Yip L., Wong E.P.Y., Yong V., Wong H.T. & Lim B.A. (2013). The effect of adjuvant mitomycin C in ahmed glaucoma valve surgery for refractory glaucoma. Investigative Ophthalmology and Visual Science, 54(15), no pagination. Retrieved from http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed14&NEWS=N&AN=628682336.

  BACKGROUND

• Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozerturk Y. The effect of adjunctive Mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan-Feb;15(1):27-31.

  PMID: 15751236 BACKGROUND

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MeSH Terms

Conditions

Glaucoma

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Sharan Bains

CONTACT

905-522-1155; bainss@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: There will be no blinding of the ophthalmologist to participant's study group as they will need the information to execute the correct intervention. The type of treatment received (mitomycin-C or no intervention) will be blinded for the patient, and all patients will be asked at the last follow-up visit which treatment location they felt they received. This data will be used to assess the level of treatment masking. The success of blinding will be calculated using Bang's Blinding Index. The person performing statistical analysis will be blinded to the intervention groups. The groups will be coded and the analyst will be unaware of which group receives mitomycin-C or no intervention with the Ahmed valve implant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: The study design is a parallel-armed clinical superiority randomized trial. The study participants will be blinded to the use of the mitomycin-c with the Ahmed valve implant. Participants will be randomly allocated to either the experimental group using mitomycin-c injections or the control group receiving no intervention. The trial will be conducted at the Hamilton Regional Eye Clinic at St. Joseph's Healthcare Hamilton to maintain standardization of care and follow-up.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: November 8, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share