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warnings
Warnings CMV retinitis may be associated with CMV disease elsewhere in the body. The Vitrasert Implant provides localized therapy limited to the implanted eye. The Vitrasert Implant does not provide treatment for systemic CMV disease. Patients should be monitored for extraocular CMV disease. As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place the Vitrasert Implant into the vitreous cavity may include, but are not limited to, the following: vitreous loss, vitreous hemorrhage, cataract formation, retinal detachment, uveitis, endophthalmitis, and decrease in visual acuity. Following implantation of the Vitrasert Implant, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately two to four weeks post-operatively. This decrease in visual acuity is likely a result of the surgical implant procedure.
Adverse Reactions During clinical trials, the most frequent adverse events seen in patients treated with the Vitrasert Implant involved the eye. During the first two months following implantation, visual acuity loss of 3 lines or more, vitreous hemorrhage, and retinal detachments occurred in approximately 10-20% of patients. Cataract formation/lens opacities, macular abnormalities, intraocular pressure spikes, optic disk/nerve changes, hyphemas and uveitis occurred in approximately 1-5%. Adverse events with an incidence of less than 1% were: retinopathy, anterior chamber cell and flare, synechia, hemorrhage (other than vitreous), cotton wool spots, keratopathy, astigmatism, endophthalmitis, microangiopathy, sclerosis, choroiditis, chemosis, phthisis bulbi, angle closure glaucoma with anterior chamber shallowing, vitreous detachment, vitreous traction, hypotony, severe post-operative inflammation, retinal tear, retinal hole, corneal dellen, choroidal folds, pellet extrusion from scleral wound, and gliosis.