Trial Outcomes & Findings for Ahmed Glaucoma Valve Surgery With Mitomycin-C (NCT NCT02805257)

NCT ID: NCT02805257

Last Updated: 2022-05-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 119 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-05-31

Participant Flow

Participant milestones

Measure	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	Balanced Salt Solution (BSS) 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Overall Study STARTED	60	59
Overall Study COMPLETED	53	52
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	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	Balanced Salt Solution (BSS) 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Overall Study Lost to Follow-up	7	6
Overall Study Death	0	1

Baseline Characteristics

Ahmed Glaucoma Valve Surgery With Mitomycin-C

Baseline characteristics by cohort

Measure	Mitomycin-C n=60 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	Balanced Salt Solution (BSS) n=59 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS	Total n=119 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	58.76 years STANDARD_DEVIATION 14.8 • n=7 Participants	55.6 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Chinese	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Mexican	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Region of Enrollment China	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Mexico	51 participants n=5 Participants	48 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Intraocular Pressure After Surgery	13.1 mmHg Standard Deviation 6.3	16.2 mmHg Standard Deviation 6.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Intraocular Pressure After Surgery	14.6 mmHg Standard Deviation 8.0	16.1 mmHg Standard Deviation 6.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Number of Medications Postoperatively	1.2 glaucoma drops Standard Deviation 0.4	1.6 glaucoma drops Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Mitomycin-C n=52 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	Balanced Salt Solution (BSS) n=46 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Visual Acuity	12.81 score on a scale Standard Deviation 6.98	15.33 score on a scale Standard Deviation 6.84

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Number of Medications Postoperatively	1.2 glaucoma drops Standard Deviation 0.3	1.6 glaucoma drops Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Number of Participants With Intraoperative Complications Other	0 participants	1 participants
Number of Participants With Intraoperative Complications Hyphema	3 participants	5 participants
Number of Participants With Intraoperative Complications Suprachoroidal Hemorrhage	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Mitomycin-C n=50 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	Balanced Salt Solution (BSS) n=44 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Visual Acuity	12.4 score on a scale Standard Deviation 7.33	16 score on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mitomycin-C n=53 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	Balanced Salt Solution (BSS) n=52 Participants 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Number of Participants With Postoperative Complications Tube occlusion	3 participants	1 participants
Number of Participants With Postoperative Complications Choroidal effusion	2 participants	1 participants
Number of Participants With Postoperative Complications Suprachoroidal hemorrhage	1 participants	2 participants
Number of Participants With Postoperative Complications Hyphema	6 participants	7 participants
Number of Participants With Postoperative Complications Vitreous hemorrhage	1 participants	2 participants
Number of Participants With Postoperative Complications Shallow Anterior Chamber	9 participants	9 participants
Number of Participants With Postoperative Complications Corneal edema	1 participants	0 participants
Number of Participants With Postoperative Complications Endophthalmitis, cystoid macular edema, hypotony maculopathy, tube-K touch, tube erosion, diplopia	2 participants	0 participants
Number of Participants With Postoperative Complications Other	8 participants	6 participants

Adverse Events

Mitomycin-C

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Balanced Salt Solution (BSS)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mitomycin-C n=53 participants at risk 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol	Balanced Salt Solution (BSS) n=52 participants at risk 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS
Eye disorders Tube Occlusion	5.7% 3/53 • 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."	1.9% 1/52 • 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."
Eye disorders Choroidal Effusion	3.8% 2/53 • 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."	1.9% 1/52 • 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."
Eye disorders Suprachoroidal hemorrhage	1.9% 1/53 • 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."	3.8% 2/52 • 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."
Eye disorders Hyphema	11.3% 6/53 • 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."	13.5% 7/52 • 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."
Eye disorders Vitreous hemorrhage	1.9% 1/53 • 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."	3.8% 2/52 • 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."
Eye disorders Shallow Anterior Chamber	17.0% 9/53 • 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."	17.3% 9/52 • 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."
Eye disorders Corneal edema	1.9% 1/53 • 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."	0.00% 0/52 • 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."
Eye disorders Other	15.1% 8/53 • 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."	11.5% 6/52 • 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."

Additional Information

Ying Han, MD, PhD

University of California, San Francisco

Phone: 415-476-3321

Email: ying.han@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place