Primary Open Angle Glaucoma
Conditions
Keywords
Primary open angle glaucoma, trabeculectomy, mitomycin-C, express mini-shunt
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.
Interventions
PROCEDUREPlacement of the sponge
DRUGMitomycin-C
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 9. Conjunctival scarring precluding a superonasal implantation location. 10. Vitreous in the anterior chamber. 11. Abnormality preventing reliable applanation tonometry in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 45 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Sponge Placement of Mitomycin-C | Total | Irrigation Placement of Mitomycin-C |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 9.6 | 70.4 years STANDARD_DEVIATION 9.3 | 73.1 years STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 42 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 46 Participants | 23 Participants |
| Region of Enrollment United States | 50 participants | 95 participants | 45 participants |
| Sex: Female, Male Female | 30 Participants | 53 Participants | 23 Participants |
| Sex: Female, Male Male | 20 Participants | 42 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 1 / 45 |
| other Total, other adverse events | 29 / 50 | 28 / 45 |
| serious Total, serious adverse events | 0 / 50 | 0 / 45 |
Outcome results
Primary
Complication Rates
To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation
Time frame: post-operative day 1 to month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sponge Placement of Mitomycin-C | Complication Rates | 29 Participants |
| Irrigation Placement of MMC | Complication Rates | 28 Participants |
p-value: 0.795% CI: [0.67, 1.29]Chi-squared
Secondary
Change in Intraocular Pressure
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
Population: Five participants in each group were not included due to being lost to follow-up or deceased.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sponge Placement of Mitomycin-C | Change in Intraocular Pressure | -8.4 mmHg (millimeters of mercury) | Standard Deviation 1.6 |
| Irrigation Placement of MMC | Change in Intraocular Pressure | -8.2 mmHg (millimeters of mercury) | Standard Deviation 1.2 |
p-value: 0.539t-test, 1 sided