Ahmed Glaucoma Valve Surgery With Mitomycin-C

Glaucoma Clinical Trial

— AMCT  

Official title:

Ahmed Glaucoma Valve Surgery With Mitomycin-C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805257
• Other study ID #: IRB#16-18935
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Glaucoma, Open-Angle
• Neovascular Glaucoma
• Primary Open Angle Glaucoma
• Secondary Glaucoma

Intervention

Drug:
• Mitomycin-C
Intraoperative and postoperative injections of mitomycin-c/Mitosol

Other:
• Balanced Salt Solution
Intraoperative and postoperative injections of BSS

Procedure:
• Ahmed Glaucoma Valve Implant
Implantation of Ahmed Valve in study eye

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong
India	Shri Ganesh Vinayak Eye Hospital	Raipur	Chhattisgarh
Mexico	Asociación para Evitar la Ceguera en México (APEC)	Mexico City
United States	University of California, San Francisco	San Francisco	California

Sponsors (9)

Lead Sponsor	Collaborator
University of California, San Francisco	Asociación para Evitar la Ceguera en México, Bascom Palmer Eye Institute, Hospital Central Militar, Shri Ganesh Vinayak Eye Hospital, University of Colorado, Denver, University of Maryland, University of North Carolina, Zhongshan Ophthalmic Center, Sun Yat-sen University

Countries where clinical trial is conducted

United States,  China,  India,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year
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.	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.	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.	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.	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.	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.	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.	1 Year