Efficacy and Safety of Ahmed ClearPath and Baerveldt Non-Valved Drainage Device Implants in the Treatment of Refractory and/or High-Risk Glaucoma: A Randomized Clinical Trial.

• Grant number: 25/00567-8
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2025
• End date: April 30, 2026
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Ivan Maynart Tavares
• Grantee: Leopoldo Pizani D'Avila e Silva
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Glaucoma is the leading cause of irreversible blindness worldwide. Refractory glaucoma is a subtype in which clinical and surgical antiglaucoma treatments have been unable to control intraocular pressure. Drainage implants are important options for managing patients with a history of surgical failure of filtering procedures or in high-risk glaucomas, such as neovascular or uveitic glaucoma, where trabeculectomy has a poor prognosis due to a higher risk of failure. The use of new non-valved implants lacks comparative studies between different devices. The objective of this study is to prospectively compare the efficacy and safety of the non-valved Ahmed ClearPath® (ACP, New World Medical Inc., Rancho Cucamonga, CA, USA) and Baerveldt® (BGI, Advanced Medical Optics Inc., Irvine, CA, USA) implants in refractory or high-risk glaucoma patients with a high likelihood of filtering surgery failure. Methods: This is a prospective randomized clinical trial in which 150 eyes with refractory or high-risk glaucoma for filtering surgery failure and indications for drainage device implantation will be allocated into the study group (Ahmed ClearPath drainage device) and the control group (Baerveldt drainage device). Intraocular pressure, visual acuity, the number of antiglaucoma medications, the need for further antiglaucoma surgeries, and perioperative and postoperative complications will be evaluated between the groups and the pre, peri, and postoperative periods. (AU)