Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
Condition: Glaucoma Open-Angle Primary; Glaucoma; Open Angle Glaucoma; Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Mitomycin C
Intervention description: Three delivery methods of Mitomycin-C in Trabeculectomy
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trabeculectomy; Mitomycin-C; Glaucoma

Summary:

      In this Pilot explorative study, the investigators are going to estimate and compare the
      outcomes of three different delivery methods of MMC for Trabeculectomy: a subconjunctival
      injection of MMC 0.002% at the site of future Trabeculectomy two to four weeks before the
      surgery, a subconjunctival injection of MMC 0.01% intraoperatively and topical sponge applied
      MMC 0.02% intraoperatively (typical use) in patients with Primary Open Angle Glaucoma who did
      not have any filtering surgeries before.

      After obtaining informed consent from the patients, the patients are randomly divided into
      three groups via a block randomization method: Group A receives 0.1 mL MMC 0.002 % (0.1mL MMC
      0.02mg/mL) subconjunctival injection preoperatively in superior conjunctiva at the site of
      future Trabeculectomy surgery. Group B receives 0.1mL MMC 0.01% subconjunctival injection
      intraoperatively at the site of Trabeculectomy and Group C receives conventional sponge
      delivery of MMC 0.02% intraoperatively. To avoid observer bias during postoperative
      evaluation of results, IOP staff obtaining measurements of IOP will be masked to the
      randomization allocation.

      All groups undergo conventional Trabeculectomy surgery (fornix-based) as scheduled, and the
      same routine follow up and post-op regimen will be scheduled for all three groups. Patients
      are routinely visited in the clinic at first day postoperatively, one week (+/-2 days), one
      month (+/-1 week), three months (+/-2 weeks), six months (+/-3 weeks) and finally at one year
      (+/-(4 weeks)). In each of these visits we will be assessing: Visual acuity, intraocular
      pressure, number and type of glaucoma medication, slit lamp examination of the anterior
      segment and fundus examination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 20 - 85 years

          -  Willingness to participate in the study by signing informed consent

          -  Primary open angle glaucoma (including pigmentary glaucoma and pseudoexfoliation
             glaucoma) indicated with open angles upon previous gonioscopy and demonstrative optic
             nerve and visual field damage

          -  Trabeculectomy needed as treatment as determined by the care provider

        Exclusion Criteria:

          -  Patient unwilling or unable to give informed consent, unwilling to accept
             randomization, or unable to return for scheduled study visits throughout the duration
             of the study (1 year)

          -  Any secondary cause of glaucoma, or angle closure shown on gonioscopy

          -  Any ocular or neurological problems with optic nerve or visual field defect (ie.
             retinal disease, post trauma, corneal scar) that may confound the interpretation of
             glaucoma such as visual field or optic nerve interpretation

          -  Pregnant women, nursing women, and/or anyone with a history of allergy to MMC