NCT02016898

Brief Summary

The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

December 16, 2013

Results QC Date

January 11, 2018

Last Update Submit

January 11, 2018

Conditions

Primary Open Angle Glaucoma

Keywords

Primary open angle glaucomatrabeculectomymitomycin-Cexpress mini-shunt

Outcome Measures

Primary Outcomes (1)

  • Complication Rates

    To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation

    post-operative day 1 to month 6

Secondary Outcomes (1)

  • Change in Intraocular Pressure

    post-operative day 1 to month 6

Study Arms (2)

Sponge placement of Mitomycin-C

EXPERIMENTAL

Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.

Procedure: Placement of the spongeDrug: Mitomycin-C

Irrigation placement of Mitomycin-C

EXPERIMENTAL

Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.

Drug: Mitomycin-C

Interventions

Placement of the spongePROCEDURE
Sponge placement of Mitomycin-C
Mitomycin-CDRUG
Irrigation placement of Mitomycin-CSponge placement of Mitomycin-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 18 years and older at screening.
  • Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.
  • Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with MMC in the superonasal quadrant in the study eye which the physician deems as medically necessary.
  • Capable and willing to provide consent

You may not qualify if:

  • Unable or unwilling to provide consent
  • Any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the superonasal quadrant
  • Any previous glaucoma drainage devices in the study eye
  • Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.
  • Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
  • Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
  • Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Known Pregnancy or Breastfeeding
  • Physical and Laboratory Findings
  • Conjunctival scarring precluding a superonasal implantation location.
  • Vitreous in the anterior chamber.
  • Abnormality preventing reliable applanation tonometry in the study eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Quist MS, Brown N, Bicket AK, Herndon LW. The Short-term Effect of Subtenon Sponge Application Versus Subtenon Irrigation of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device: A Randomized Trial. J Glaucoma. 2018 Feb;27(2):148-156. doi: 10.1097/IJG.0000000000000830.

    PMID: 29189540DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Michael Quist, MD
Organization
Duke University Health System
michael.quist@duke.edu
718-490-7657

Study Officials

  • Leon Herndon, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

March 1, 2014

Primary Completion

January 17, 2017

Study Completion

January 17, 2017

Last Updated

February 9, 2018

Results First Posted

February 9, 2018

Record last verified: 2018-01

Locations

US(1)