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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of the sponge | Procedure |
| ||
| Mitomycin-C |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rates | To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation | post-operative day 1 to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure | To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation | post-operative day 1 to month 6 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Leon Herndon, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29189540 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sponge Placement of Mitomycin-C | 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 |
| FG001 | Irrigation Placement of Mitomycin-C |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Placement of the sponge Mitomycin-C |
| BG001 | 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. Irrigation placement Mitomycin-C |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complication Rates | To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation | Posted | Count of Participants | Participants | post-operative day 1 to month 6 |
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| Secondary | Change in Intraocular Pressure | To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation | Five participants in each group were not included due to being lost to follow-up or deceased. | Posted | Mean | Standard Deviation | mmHg (millimeters of mercury) | post-operative day 1 to month 6 |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sponge Placement of Mitomycin-C | 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 | 1 | 50 | 0 | 50 | 29 | 50 |
| EG001 | Irrigation Placement of 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 | 1 | 45 | 0 | 45 | 28 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystic blebs | Eye disorders | Systematic Assessment |
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| Shallowing of anterior chamber | Eye disorders | Systematic Assessment |
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| Hypotony | Eye disorders | Systematic Assessment |
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| Choroidal effusion | Eye disorders | Systematic Assessment |
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| Suprachoroidal hemorrhage | Eye disorders | Systematic Assessment |
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| Hyphema | Eye disorders | Systematic Assessment |
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| Wound leak | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Quist, MD | Duke University Health System | 718-490-7657 | michael.quist@duke.edu |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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