Status:
TERMINATED
Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
Lead Sponsor:
University of California, Los Angeles
Conditions:
Glaucoma Open-Angle Primary
Glaucoma
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief 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 0.00...
Detailed Description
Purpose: To obtain estimates of the effect on intraocular pressure and side effects of three delivery methods of Mitomycin C (MMC) compared among each other: preoperative subconjunctival injection of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03875911
Start Date
March 30 2019
End Date
December 31 2022
Last Update
January 5 2024
Active Locations (4)
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1
Doheny Eye Center UCLA (Arcadia)
Arcadia, California, United States, 91007
2
Doheny Eye Center UCLA (Fountain Valley)
Fountain Valley, California, United States, 92708
3
Stein Eye Institute - UCLA (Westwood)
Los Angeles, California, United States, 90049
4
Doheny Eye Center UCLA (Pasadena)
Pasadena, California, United States, 91105