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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02016898
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 34.6
• Patients Per Site Per Month: 2.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Procedure: Placement of the sponge; Drug: Mitomycin-C	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jan 17, 2017
• Actual Study Completion Date: Jan 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sponge placement of Mitomycin-C 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 sponge; Drug: Mitomycin-C
Experimental: Irrigation placement of Mitomycin-C 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

Outcome Measures

Primary Outcome Measures

1. Complication Rates [post-operative day 1 to month 6]

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

Secondary Outcome Measures

1. Change in Intraocular Pressure [post-operative day 1 to month 6]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men or women aged 18 years and older at screening.

2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.

3. 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.

4. Capable and willing to provide consent

Exclusion Criteria:

1. Unable or unwilling to provide consent

2. 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

3. Any previous glaucoma drainage devices in the study eye

4. Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.

5. Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.

6. Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.

7. Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

8. Known Pregnancy or Breastfeeding

Physical and Laboratory Findings

1. Conjunctival scarring precluding a superonasal implantation location.

2. Vitreous in the anterior chamber.

3. Abnormality preventing reliable applanation tonometry in the study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Leon Herndon, MD, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02016898
• Other Study ID Numbers: Pro00048136
• First Posted: Dec 20, 2013
• Last Update Posted: Feb 9, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Duke University: Primary open angle glaucoma; trabeculectomy; mitomycin-C; express mini-shunt
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Mitomycins; Mitomycin

Study Results

Participant Flow

Pre-assignment Detail	Two subjects were retroactively removed due to not satisfying the inclusion/exclusion criteria. An additional three subjects had uncertain group allocation due to clerical errors.

Arm/Group Title	Sponge Placement of Mitomycin-C	Irrigation Placement of Mitomycin-C
Arm/Group Description	Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Placement of the sponge Mitomycin-C	Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Irrigation placement Mitomycin-C
Period Title: Overall Study
STARTED	50	45
COMPLETED	45	40
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Sponge Placement of Mitomycin-C	Irrigation Placement of Mitomycin-C	Total
Arm/Group 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. Placement of the sponge Mitomycin-C	Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Irrigation placement Mitomycin-C	Total of all reporting groups
Overall Participants	50	45	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (9.6)	73.1 (8.3)	70.4 (9.3)
Sex: Female, Male (Count of Participants)
Female	30 60%	23 51.1%	53 55.8%
Male	20 40%	22 48.9%	42 44.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	3 6.7%	3 3.2%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.2%	1 1.1%
Black or African American	26 52%	16 35.6%	42 44.2%
White	23 46%	23 51.1%	46 48.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2%	2 4.4%	3 3.2%
Region of Enrollment (participants) [Number]
United States	50 100%	45 100%	95 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sponge Placement of Mitomycin-C	Irrigation Placement of MMC
Arm/Group Description	Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Placement of the sponge Mitomycin-C	Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Irrigation placement Mitomycin-C
Measure Participants	50	45
Count of Participants [Participants]	29 58%	28 62.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sponge Placement of Mitomycin-C, Irrigation Placement of MMC
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Five participants in each group were not included due to being lost to follow-up or deceased.

Arm/Group Title	Sponge Placement of Mitomycin-C	Irrigation Placement of MMC
Arm/Group Description	Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Placement of the sponge Mitomycin-C	Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Irrigation placement Mitomycin-C
Measure Participants	45	40
Mean (Standard Deviation) [mmHg (millimeters of mercury)]	-8.4 (1.6)	-8.2 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sponge Placement of Mitomycin-C, Irrigation Placement of MMC
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.539
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 2.01
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Sponge Placement of Mitomycin-C		Irrigation Placement of Mitomycin-C
Arm/Group Description	Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Placement of the sponge Mitomycin-C		Randomization stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery. Irrigation placement Mitomycin-C
All Cause Mortality
	Sponge Placement of Mitomycin-C		Irrigation Placement of Mitomycin-C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		1/45 (2.2%)
Serious Adverse Events
	Sponge Placement of Mitomycin-C		Irrigation Placement of Mitomycin-C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Sponge Placement of Mitomycin-C		Irrigation Placement of Mitomycin-C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/50 (58%)		28/45 (62.2%)
Eye disorders
Cystic blebs	8/50 (16%)		5/45 (11.1%)
Shallowing of anterior chamber	1/50 (2%)		3/45 (6.7%)
Hypotony	5/50 (10%)		14/45 (31.1%)
Choroidal effusion	3/50 (6%)		3/45 (6.7%)
Suprachoroidal hemorrhage	0/50 (0%)		1/45 (2.2%)
Hyphema	1/50 (2%)		1/45 (2.2%)
Wound leak	18/50 (36%)		14/45 (31.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.