Ahmed Glaucoma Valve Surgery With Mitomycin-C (AMCT)
Primary Purpose
Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mitomycin-C
Balanced Salt Solution
Ahmed Glaucoma Valve Implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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.
Sites / Locations
- University of California, San Francisco
- Zhongshan Ophthalmic Center
- Shri Ganesh Vinayak Eye Hospital
- Asociación para Evitar la Ceguera en México (APEC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mitomycin-C
Balanced Salt Solution (BSS)
Arm Description
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02805257
First Posted
June 15, 2016
Last Updated
May 27, 2022
Sponsor
University of California, San Francisco
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02805257
Brief Title
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Acronym
AMCT
Official Title
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma, Neovascular Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitomycin-C
Arm Type
Experimental
Arm Description
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Arm Title
Balanced Salt Solution (BSS)
Arm Type
Placebo Comparator
Arm Description
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Intervention Type
Drug
Intervention Name(s)
Mitomycin-C
Other Intervention Name(s)
Mitosol
Intervention Description
Intraoperative and postoperative injections of mitomycin-c/Mitosol
Intervention Type
Other
Intervention Name(s)
Balanced Salt Solution
Other Intervention Name(s)
BSS
Intervention Description
Intraoperative and postoperative injections of BSS
Intervention Type
Procedure
Intervention Name(s)
Ahmed Glaucoma Valve Implant
Intervention Description
Implantation of Ahmed Valve in study eye
Primary Outcome Measure Information:
Title
Intraocular Pressure After Surgery
Description
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
Secondary Outcome Measure Information:
Title
Intraocular Pressure After Surgery
Description
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
Title
Number of Medications Postoperatively
Description
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
Title
Visual Acuity
Description
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
Title
Number of Medications Postoperatively
Description
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
Title
Number of Participants With Intraoperative Complications
Description
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
Title
Visual Acuity
Description
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
Title
Number of Participants With Postoperative Complications
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Han, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shri Ganesh Vinayak Eye Hospital
City
Raipur
State/Province
Chhattisgarh
Country
India
Facility Name
Asociación para Evitar la Ceguera en México (APEC)
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plans to share IPD to other researchers.
Learn more about this trial
Ahmed Glaucoma Valve Surgery With Mitomycin-C
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