Xen 45 implant versus Deep Sclerectomy in the surgical treatment of open angle glaucoma: A comparative study in a South African tertiary hospital - Trial PACTR201906908757116

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Summary

Problem statementDeep sclerectomy augmented with MMC has a proven track record for use in open-angle glaucoma patients that require surgery to control their intraocular pressure, but the procedure is not without complications and is not always successful. Newer glaucoma surgical devices, of which the Xen 45 implant is an example, offer the following potential advantages over conventional surgery:• Shorter surgical time• Fewer complicationsThese benefits may improve the cost-effectiveness of the Xen 45 implant, an otherwise expensive device, but only if the device is equally effective in lowering IOP and if the requirements for post-operative follow-up visits, procedures and medications are comparable. It is not known, therefore, whether this procedure is a feasible alternative to deep sclerectomy in the resource-constrained setting of the Charlotte Maxeke Johannesburg Academic (CMJA) Hospital in Johannesburg, South Africa.Research QuestionIs the Xen 45 gel implant a cost-effective alternative procedure to deep sclerectomy at CMJA Hospital?Aim of the studyTo compare the cost-effectiveness of Xen implants versus deep sclerectomy in patients with open-angle glaucoma over a six-month period.Study objectivesPrimary objective• To cost Xen implant surgery and follow-up over a six-month period and compare it to the cost of deep sclerectomy surgery and six-month follow-up at CMJAH Secondary objectives• To compare IOP outcomes in the first two years after Xen implant surgery with those following deep sclerectomy surgery• To compare the success and failure rates of the two procedures at six months, one and two years post-operatively• To compare the post-operative requirement for glaucoma medication following Xen implants with that following deep sclerectomy surgery• To compare the complication (intra- and post-operative) rates of Xen implant surgery with deep sclerectomy surgery

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