Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy

Stopped early · Phase 4

Conditions studied: Glaucoma Open-Angle Primary, Glaucoma, Open Angle Glaucoma, Glaucoma, Open-Angle

In brief

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.

Key facts

Study ID

NCT03875911

Run by

University of California, Los Angeles

People needed

19

Starts

2019-03-30

Expected to finish

2022-12-31

Last updated by the study team

2024-01-05

Who can join

Age: 20 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Doheny Eye Center UCLA (Arcadia) — Arcadia, California, United States
• Doheny Eye Center UCLA (Fountain Valley) — Fountain Valley, California, United States
• Stein Eye Institute - UCLA (Westwood) — Los Angeles, California, United States
• Doheny Eye Center UCLA (Pasadena) — Pasadena, California, United States

Full record on ClinicalTrials.gov

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