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The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Primary Purpose

Primary Open Angle Glaucoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placement of the sponge

Mitomycin-C

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary open angle glaucoma, trabeculectomy, mitomycin-C, express mini-shunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sponge placement of Mitomycin-C

Irrigation placement of Mitomycin-C

Arm Description

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

Outcomes

Primary Outcome Measures

Complication Rates

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

Secondary Outcome Measures

Change in Intraocular Pressure

To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation

Full Information

NCT ID

NCT02016898

First Posted

December 16, 2013

Last Updated

January 11, 2018

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02016898

Brief Title

The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Official Title

The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma

Keywords

Primary open angle glaucoma, trabeculectomy, mitomycin-C, express mini-shunt

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sponge placement of Mitomycin-C

Arm Type

Experimental

Arm Description

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

Arm Title

Irrigation placement of Mitomycin-C

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Placement of the sponge

Intervention Type

Drug

Intervention Name(s)

Mitomycin-C

Primary Outcome Measure Information:

Title

Complication Rates

Description

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

Time Frame

post-operative day 1 to month 6

Secondary Outcome Measure Information:

Title

Change in Intraocular Pressure

Description

To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation

Time Frame

post-operative day 1 to month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leon Herndon, MD

Organizational Affiliation

Duke Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29189540

Citation

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.

Results Reference

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The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

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