The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma
Completed · Not applicable
Conditions studied: Glaucoma
In brief
The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from multiple study centers and randomized to a glaucoma drainage device for implantation. They will be followed long-term based upon outcome measures including intraocular pressure, glaucoma medication use, visual acuity, complications of the surgery and further treatments required.
Key facts
- Study ID
- NCT00940823
- Run by
- Credit Valley EyeCare
- People needed
- 238
- Starts
- 2005-07-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2018-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than or equal to 18.
- Inadequately controlled glaucoma determined as intraocular pressure (IOP) greater than target, which has not responded to conventional medical and surgical therapy.
- Patients with significant conjunctival scarring or high-risk disease (active neovascular glaucoma) precluding antimetabolite trabeculectomy will be included in the study.
- Provide written informed consent to participate in the study.
You may not qualify if…
- Age less than 18.
- Patient will undergo an additional procedure at the time of glaucoma drainage device implantation (i.e. lensectomy, penetrating keratoplasty)
- No light perception vision.
- Patient has already been enrolled in the study in the contralateral eye.
- Patient is unwilling or unable to provide informed consent to participate in the study, or adhere to the study requirements including implant randomization and required follow-up visits.
Where it is running
- Eugene and Marilyn Glick Eye Institute — Indianapolis, Indiana, United States
- Vanderbilt Eye Institute — Nashville, Tennessee, United States
- Drs. Massaro and Kalenak — Milwaukee, Wisconsin, United States
- Credit ValleyEC — Toronto, Ontario, Canada
- Montreal Glaucoma Institute — Montreal, Quebec, Canada
- Clinic of Las Condes — Santiago, Chile
Full record on ClinicalTrials.gov
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