Alberta Heritage Foundation for Medical Research
Record ID 32000000860
Authors' objectives: This report aims to summarise the available evidence on the use of AquaFlow(R) in the treatment of glaucoma.
Authors' recomendations: AquaFlow(R) is a collagen glaucoma drainage extraocular implant that has been trialled at nine centres in the USA. It is designed for the treatment of open-angle, post-traumatic, pigmentary or concussion glaucoma in association with sclerotomy. The manufacturer, STAAR Surgical Company, has announced plans to file for pre-market approval in the USA. The device is permanently implanted inside the eye just under the sclera without penetrating the eyeball. The proprietary polymerized collagen material in the device slowly dissolves over 6-9 months. Insertion of AquaFlow is performed on an outpatient basis. About 200 persons have so far been recruited for clinical trials and are being followed up for a minimum of two years. The company reports that in the US study, patients' eyes demonstrated excellent intraocular pressure (IOP), which allowed them to discontinue use of almost all glaucoma medications. Postoperative complications were rare and generally occurred at lower rates than traditional glaucoma procedures, such as trabeculectomy. These data are said to be consistent with those from a study in Switzerland by Mermoud and colleagues. In that controlled trial, the success rate, defined as an IOP <21.0 mm Hg without medication was 69% in the collagen implant group and 57% in the trabeculectomy group at 24 months postoperatively. It was concluded that the success rates of the two approaches may be comparable, but that deep sclerectomy with a collagen implant has fewer complications.
Authors' methods: Overview
Project Status: Completed
Year Published: 2000
URL for published report: https://www.ihe.ca/advanced-search?type=1020
English language abstract: An English language summary is available
Publication Type: Not Assigned
Organisation Name: Institute of Health Economics
Contact Address: 1200, 10405 Jasper Avenue, Edmonton, Alberta, Canada, T5J 3N4. Tel: +1 780 448 4881; Fax: +1 780 448 0018;
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Copyright: Alberta Heritage Foundation for Medical Research (AHFMR)
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