Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03875911
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph Caprioli, University of California, Los Angeles

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 0.002% 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.


Condition or disease Intervention/treatment Phase
Glaucoma Open-Angle Primary Glaucoma Open Angle Glaucoma Glaucoma, Open-Angle Drug: Mitomycin C Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial Comparing Three Delivery Methods of Mitomycin-C for Trabeculectomy Surgery: Preoperative Subconjunctival Injection, Intraoperative Subconjunctival Injection, and Topical Application (Conventional Use) During Trabeculectomy Surgery
Estimated Study Start Date : March 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Preoperative Subconjunctival injection of MMC
Subconjunctival injection of 0.1 ml of Mitomycin-C 0.002% at the site of future trabeculectomy surgery (2 - 4 weeks preoperatively).
Drug: Mitomycin C
Three delivery methods of Mitomycin-C in Trabeculectomy

Active Comparator: Intraoperative subconjunctival injection of MMC
Intraoperative subjconjunctival injection of 0.1 mL of Mitomycin-C 0.01% (0.1mg/mL) to the site of trabeculectomy
Drug: Mitomycin C
Three delivery methods of Mitomycin-C in Trabeculectomy

Active Comparator: Intraoperative topical application of MMC
Topical application of Mitomycin-C intraoperatively by applying a sponge soaked in 1mL of Mitomycin-C 0.02 mg/mL for 1 minute to the site of trabeculectomy
Drug: Mitomycin C
Three delivery methods of Mitomycin-C in Trabeculectomy




Primary Outcome Measures :
  1. Intraocular Pressure Reduction [ Time Frame: we want to perform pairwise comparisons among three groups and obtain the mean IOP estimates at each time point up to one year ]
    Since the literature on the effect of preoperative subconjunctival injection and intraoperative subconjunctival injections for trabeculectomy shows inconsistent results and there are no estimates available for the IOP reduction among all three methods, the primary objective is to obtain such estimates in this pilot study. Hence, we want to perform pairwise comparisons among three groups and obtain the mean IOP estimates at each time point up to one year. The sample size for each randomized group will be 50 patients (a total of 150 patients) taking in consideration the patient flow and recruitment for trabeculectomy surgery at the Glaucoma Division.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875911


Contacts
Layout table for location contacts
Contact: Diane Ngo, BS 3108256323 d.ngo@jsei.ucla.edu
Contact: Ellen Pascual 310-794-5592 pascual@jsei.ucla.edu

Locations
Layout table for location information
United States, California
Doheny Eye Center UCLA (Arcadia) Recruiting
Arcadia, California, United States, 91007
Contact: Diane Ngo, BS    310-825-6323    d.ngo@jsei.ucla.edu   
Sub-Investigator: Vikas Chopra, MD         
Sub-Investigator: Brian Francis, MD         
Sub-Investigator: James Tan, MD         
Doheny Eye Center UCLA (Fountain Valley) Recruiting
Fountain Valley, California, United States, 92708
Contact: Diane Ngo, BS    310-825-6323    d.ngo@jsei.ucla.edu   
Sub-Investigator: Brian Francis, MD         
Stein Eye Institute - UCLA (Westwood) Recruiting
Los Angeles, California, United States, 90049
Contact: Diane Ngo, BS    310-825-6323    d.ngo@jsei.ucla.edu   
Contact: Ellen Pascual    310-794-5592    pascual@jsei.ucla.edu   
Principal Investigator: Joseph Caprioli, MD         
Sub-Investigator: Anne Coleman, MD, PhD         
Sub-Investigator: Simon Law, MD, PharmD         
Sub-Investigator: JoAnn Giaconi, MD         
Sub-Investigator: Kouros Nouri-Mahdavi, MD, MSc         
Doheny Eye Center UCLA (Pasadena) Recruiting
Pasadena, California, United States, 91105
Contact: Diane Ngo, BS    310-825-6323    d.ngo@jsei.ucla.edu   
Sub-Investigator: Vikas Chopra, MD         
Sub-Investigator: Brian Francis, MD         
Sub-Investigator: James Tan, MD         
Sub-Investigator: Alex Huang, MD         
Sponsors and Collaborators
University of California, Los Angeles

Layout table for additonal information
Responsible Party: Joseph Caprioli, Distinguished Professor of Ophthalmology and David May II Chair in Ophthalmology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03875911     History of Changes
Other Study ID Numbers: 17-000432
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Joseph Caprioli, University of California, Los Angeles:
Trabeculectomy
Mitomycin-C
Glaucoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Eye Diseases
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors