Double blind, randomised, placebo controlled, crossover, multicentre study to determine the eYcacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) Abstract Background/aims-Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the eYcacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome. Methods-A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment. Results-70 subjects were included in the analyses of eYcacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the eVectiveness of two treatments, a majority of subjects felt that hyaluronan was more eVective than saline in alleviating the symptoms of burning and grittiness (p<0.001). No adverse events attributable to hyaluronan treatment were reported. Conclusion-The study demonstrates a clear benefit of hyaluronan over saline, in both subjective and objective assessments of dry eye syndrome. Hyaluronan was shown to be well tolerated.
Ophthalmic assessments of 120 patients with homozygous sickle cell (SS) disease and of 222 with sickle cell haemoglobin-C (SC) disease were conducted over a period of ten years. Visual acuity loss (V.A. less than or equal to 6/18) attributable to sickle cell retinopathy occurred in 10% of untreated eyes during a mean observation period of 6.9 years. Visual loss was strongly associated with proliferative sickle retinopathy (p less than 0.001) and most commonly resulted from vitreous haemorrhage, tractional retinal detachment and epiretinal membranes. The incidence of visual loss was 31 per 1000 eye-years observation among eyes with proliferative disease compared to 1.4 per 1000 eye-years observation among eyes with non-proliferative disease.
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