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| Name | Class |
|---|---|
| Bascom Palmer Eye Institute | OTHER |
| University of North Carolina | OTHER |
| University of Colorado, Denver | OTHER |
| University of Maryland |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin-C | Experimental | 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. |
|
| Balanced Salt Solution (BSS) | Placebo Comparator | 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin-C | Drug | Intraoperative and postoperative injections of mitomycin-c/Mitosol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Han, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94121 | United States | ||
| Zhongshan Ophthalmic Center |
No current plans to share IPD to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Balanced Salt Solution (BSS) | 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Balanced Salt Solution (BSS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | mmHg | 1 year |
|
Over 1 Year
In our study protocol, we defined Serious Adverse Events as the following "A SAE is any adverse event that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant disability/incapacity."
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tube Occlusion | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ying Han, MD, PhD | University of California, San Francisco | 415-476-3321 | ying.han@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2017 | Nov 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2017 | Nov 18, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| C072670 | Hanks Balanced Salt Solution |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| OTHER |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | OTHER |
| Asociación para Evitar la Ceguera en México | OTHER |
| Hospital Central Militar | OTHER_GOV |
| Shri Ganesh Vinayak Eye Hospital | OTHER |
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| Balanced Salt Solution | Other | Intraoperative and postoperative injections of BSS |
|
|
| Ahmed Glaucoma Valve Implant | Procedure | Implantation of Ahmed Valve in study eye |
|
| 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 1 year |
| 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. | Day of Surgery |
| 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. | 1 year |
| 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. | 1 Year |
| Guangzhou |
| Guangdong |
| China |
| Shri Ganesh Vinayak Eye Hospital | Raipur | Chhattisgarh | India |
| Asociación para Evitar la Ceguera en México (APEC) | Mexico City | Mexico |
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Balanced Salt Solution: Intraoperative and postoperative injections of BSS
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol |
| OG001 | Balanced Salt Solution (BSS) | 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS |
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | glaucoma drops | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | glaucoma drops | 1 year |
|
|
|
| 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. | Posted | Number | participants | Day of Surgery |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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. | Posted | Number | participants | 1 Year |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 23 |
| 53 |
| EG001 | Balanced Salt Solution (BSS) | 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS | 1 | 52 | 0 | 52 | 21 | 52 |
| Choroidal Effusion | Eye disorders | Systematic Assessment |
|
| Suprachoroidal hemorrhage | Eye disorders | Systematic Assessment |
|
| Hyphema | Eye disorders | Systematic Assessment |
|
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
|
| Shallow Anterior Chamber | Eye disorders | Systematic Assessment |
|
| Corneal edema | Eye disorders | Systematic Assessment |
|
| Other | Eye disorders | Systematic Assessment |
|
Not provided
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| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Other |
|
| Suprachoroidal hemorrhage |
|
| Hyphema |
|
| Vitreous hemorrhage |
|
| Shallow Anterior Chamber |
|
| Corneal edema |
|
| Endophthalmitis, cystoid macular edema, hypotony maculopathy, tube-K touch, tube erosion, diplopia |
|
| Other |
|