Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma, Neovascular Glaucoma
Conditions
Brief summary
This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.
Detailed description
Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
Interventions
DRUGMitomycin-C
Intraoperative and postoperative injections of mitomycin-c/Mitosol
Intraoperative and postoperative injections of BSS
PROCEDUREAhmed Glaucoma Valve Implant
Implantation of Ahmed Valve in study eye
Sponsors
Bascom Palmer Eye Institute
University of North Carolina
University of Colorado, Denver
University of Maryland
Zhongshan Ophthalmic Center, Sun Yat-sen University
Asociación para Evitar la Ceguera en México
Hospital Central Militar
Shri Ganesh Vinayak Eye Hospital
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg. * Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure. * For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.
Exclusion criteria
* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. * Pregnant or nursing women. * Previous cyclodestruction or glaucoma drainage device (GDD) surgery. * Patients with nanophthalmos. * Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure. * No light perception vision. * VA \<20/200 in non-study eye. * Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery. * Previous scleral buckling procedure or silicone oil present. * Uveitic glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure After Surgery | 1 year | Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure After Surgery | 6 months | Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above. |
| Number of Medications Postoperatively | 6 months | Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure. |
| Visual Acuity | 6 months | The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness. |
| Number of Participants With Intraoperative Complications | Day of Surgery | Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed. |
| Number of Participants With Postoperative Complications | 1 Year | Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed. |
Countries
China, India, Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mitomycin-C 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol | 60 |
| Balanced Salt Solution (BSS) 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Balanced Salt Solution: Intraoperative and postoperative injections of BSS | 59 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 6 |
Baseline characteristics
| Characteristic | Mitomycin-C | Balanced Salt Solution (BSS) | Total |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 13.4 | 58.76 years STANDARD_DEVIATION 14.8 | 55.6 years STANDARD_DEVIATION 14.4 |
| Race/Ethnicity, Customized Ethnicity Chinese | 9 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized Ethnicity Mexican | 51 Participants | 48 Participants | 99 Participants |
| Region of Enrollment China | 9 participants | 11 participants | 20 participants |
| Region of Enrollment Mexico | 51 participants | 48 participants | 99 participants |
| Sex: Female, Male Female | 29 Participants | 25 Participants | 54 Participants |
| Sex: Female, Male Male | 31 Participants | 34 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 1 / 52 |
| other Total, other adverse events | 23 / 53 | 21 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
Primary
Intraocular Pressure After Surgery
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Intraocular Pressure After Surgery | 13.1 mmHg | Standard Deviation 6.3 |
| Balanced Salt Solution (BSS) | Intraocular Pressure After Surgery | 16.2 mmHg | Standard Deviation 6.2 |
Secondary
Intraocular Pressure After Surgery
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Intraocular Pressure After Surgery | 14.6 mmHg | Standard Deviation 8 |
| Balanced Salt Solution (BSS) | Intraocular Pressure After Surgery | 16.1 mmHg | Standard Deviation 6.9 |
Secondary
Number of Medications Postoperatively
Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Number of Medications Postoperatively | 1.2 glaucoma drops | Standard Deviation 0.4 |
| Balanced Salt Solution (BSS) | Number of Medications Postoperatively | 1.6 glaucoma drops | Standard Deviation 0.3 |
Secondary
Number of Medications Postoperatively
Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Number of Medications Postoperatively | 1.2 glaucoma drops | Standard Deviation 0.3 |
| Balanced Salt Solution (BSS) | Number of Medications Postoperatively | 1.6 glaucoma drops | Standard Deviation 0.4 |
Secondary
Number of Participants With Intraoperative Complications
Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.
Time frame: Day of Surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitomycin-C | Number of Participants With Intraoperative Complications | Hyphema | 3 participants |
| Mitomycin-C | Number of Participants With Intraoperative Complications | Suprachoroidal Hemorrhage | 0 participants |
| Mitomycin-C | Number of Participants With Intraoperative Complications | Other | 0 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Intraoperative Complications | Other | 1 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Intraoperative Complications | Hyphema | 5 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Intraoperative Complications | Suprachoroidal Hemorrhage | 0 participants |
Secondary
Number of Participants With Postoperative Complications
Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.
Time frame: 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitomycin-C | Number of Participants With Postoperative Complications | Hyphema | 6 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Vitreous hemorrhage | 1 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Tube occlusion | 3 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Choroidal effusion | 2 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Suprachoroidal hemorrhage | 1 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Shallow Anterior Chamber | 9 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Corneal edema | 1 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Endophthalmitis, cystoid macular edema, hypotony maculopathy, tube-K touch, tube erosion, diplopia | 2 participants |
| Mitomycin-C | Number of Participants With Postoperative Complications | Other | 8 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Suprachoroidal hemorrhage | 2 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Hyphema | 7 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Vitreous hemorrhage | 2 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Other | 6 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Corneal edema | 0 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Tube occlusion | 1 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Shallow Anterior Chamber | 9 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Choroidal effusion | 1 participants |
| Balanced Salt Solution (BSS) | Number of Participants With Postoperative Complications | Endophthalmitis, cystoid macular edema, hypotony maculopathy, tube-K touch, tube erosion, diplopia | 0 participants |
Secondary
Visual Acuity
The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.
Time frame: 1 year
Population: Unable to report visual acuity data at one year for three Mitomycin-C patients and eight Balanced Salt Solution patients due to missing data entry.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Visual Acuity | 12.4 score on a scale | Standard Deviation 7.33 |
| Balanced Salt Solution (BSS) | Visual Acuity | 16 score on a scale | Standard Deviation 7.78 |
Secondary
Visual Acuity
The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.
Time frame: 6 months
Population: Unable to report visual acuity data at six months for one Mitomycin-C patient and six Balanced Salt Solution patients due to missing data entry.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitomycin-C | Visual Acuity | 12.81 score on a scale | Standard Deviation 6.98 |
| Balanced Salt Solution (BSS) | Visual Acuity | 15.33 score on a scale | Standard Deviation 6.84 |