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Completed

NCT Number: NCT02805257

Ahmed Glaucoma Valve Surgery With Mitomycin-C

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Ophthalmic Center, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mitomycin-C

Drug

Intraoperative and postoperative injections of mitomycin-c/Mitosol

Other names: Mitosol

Balanced Salt Solution

Other

Intraoperative and postoperative injections of BSS

Other names: BSS

Ahmed Glaucoma Valve Implant

Procedure

Implantation of Ahmed Valve in study eye

Primary outcomes

  1. Intraocular Pressure After Surgery

    Time frame: 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 outcomes

  1. Intraocular Pressure After Surgery

    Time frame: 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.

  2. Number of Medications Postoperatively

    Time frame: 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.

  3. Visual Acuity

    Time frame: 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.

  4. Number of Medications Postoperatively

    Time frame: 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.

  5. Number of Participants With Intraoperative Complications

    Time frame: 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.

  6. Visual Acuity

    Time frame: 1 year

    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.

  7. Number of Participants With Postoperative Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • 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

Registry information

Acronym: AMCT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2016
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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