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D.F. Sweeney, M.S. Sridhar, A. Vannas, V.K. Pravin, R. Kala, T.C. Hughes, M.D. M. Evans, K.M. McLean, R.Z. Xie; Corneal Inlays: Results of a 6 Month Phase 1 Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4372.
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Purpose: To assess the safety of synthetic corneal inlays over a 6 month period. Methods: Porous Perfluropolyether corneal inlays (LD: 4.3mm ct: 80 microns) were placed under a microkeratome flap (180 microns thickness) without sutures in the unsighted eye of 5 patients. Three patients, aged from 58 to 68 years, were unsighted in one eye as a result of optic atrophy whilst a further 2 patients, aged 24 and 38 years, were unsighted in one eye as a result of traumatic optic neuropathy and central retinal artery occlusion. The contralteral eye had "good" vision (20/20–20/40). A microkeratome flap without implantation was performed on another 1 unsighted eye of patients aged 50 years. This patient served as a control. The patients undergoing surgery were assessed at baseline, immediately post–operative, at 7 days, 1 month and every month thereafter for 6 months. Results: Surgery for all cases was uneventful. All implants have been well tolerated with no episodes of inflammation, significant vascular in–growth or other adverse reactions reported. The position of the inlays has remained stable over the 6 month period. The clarity of the inlays has remained unchanged after an initial very slight decrease in the days immediately following surgery for 2 patients. There have been reports of slight haze overlying and around the inlays. Conclusions: Corneal inlays made from perfluoropolyether offer a safe and biologically acceptable alternative to other forms of refractive surgery.
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