Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
NCT ID: NCT06680245
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
144 participants
INTERVENTIONAL
2024-12-01
2026-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mitomycin-C Treatment
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.
Mitomycin c
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.
Control
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.
No interventions assigned to this group
Interventions
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Mitomycin c
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Enitan Sogbesan
Doctor
Central Contacts
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References
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Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.
Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.
Margolis KL, Rich EC. Open-angle glaucoma. Prim Care. 1989 Mar;16(1):197-209.
Sharts-Hopko NC, Glynn-Milley C. Primary open-angle glaucoma. Am J Nurs. 2009 Feb;109(2):40-7; quiz 48. doi: 10.1097/01.NAJ.0000345434.37734.ee.
Alasbali T, Alghamdi AA, Khandekar R. Outcomes of Ahmed valve surgery for refractory glaucoma in Dhahran, Saudi Arabia. Int J Ophthalmol. 2015 Jun 18;8(3):560-4. doi: 10.3980/j.issn.2222-3959.2015.03.22. eCollection 2015.
Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
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.
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.
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.
Amoozgar B, Lin SC, Han Y, Kuo J. A role for antimetabolites in glaucoma tube surgery: current evidence and future directions. Curr Opin Ophthalmol. 2016 Mar;27(2):164-9. doi: 10.1097/ICU.0000000000000244.
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.
Costa VP, Azuara-Blanco A, Netland PA, Lesk MR, Arcieri ES. Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: a prospective randomized clinical trial. Ophthalmology. 2004 Jun;111(6):1071-6. doi: 10.1016/j.ophtha.2003.09.037.
Kook MS, Yoon J, Kim J, Lee MS. Clinical results of Ahmed glaucoma valve implantation in refractory glaucoma with adjunctive mitomycin C. Ophthalmic Surg Lasers. 2000 Mar-Apr;31(2):100-6.
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.
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.
Bikbov MM, Khusnitdinov II. The Results of the Use of Ahmed Valve in Refractory Glaucoma Surgery. J Curr Glaucoma Pract. 2015 Sep-Dec;9(3):86-91. doi: 10.5005/jp-journals-10008-1191. Epub 2016 Feb 2.
Alvarado JA, Hollander DA, Juster RP, Lee LC. Ahmed valve implantation with adjunctive mitomycin C and 5-fluorouracil: long-term outcomes. Am J Ophthalmol. 2008 Aug;146(2):276-284. doi: 10.1016/j.ajo.2008.04.008. Epub 2008 Jun 6.
Park Y, Cho KJ. Posterior segment complications of Ahmed valve implantation. BMC Ophthalmol. 2022 Feb 15;22(1):78. doi: 10.1186/s12886-022-02297-y.
Other Identifiers
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16370
Identifier Type: -
Identifier Source: org_study_id
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