Undiluted versus Diluted Autologous Serum Eye Drops (ASED): A Prospective, Randomized, Double–Blind Study in Patients With Refractory Dry Eye–Syndrome

Abstract

Abstract: : Purpose: ASED have been used in the treatment of severe dry eye–disease. We have evaluated the efficacy of undiluted (ud) ASED compared to a 50% concentration (di) of ASED for refractory dry eye–syndrome in a prospective, randomized and double–blind fashion. Here, we present our 3–months–results of an ongoing study. Methods: Patients fulfilling ophthalmological and medical entry criteria were randomized to 3 months of udASED and diASED (1:1 in sodium chloride) to the right or left eye, respectively. Clinical assessment, including Schirmer’s test, break–up time, and fluorescein staining was performed at baseline, 2 weeks, 2 and 3 months. Examination and grading was carried out by two ophthalmologists. Subjective comfort and improvement was recorded during each visit using the ‘‘faces’’–scale (FS; 7 grades with 1 being best and 7 worst). Results are presented as the arithmetic mean. Results: Eleven patients were enrolled into the study, and 16 eyes from 8 patients could be evaluated so far. Eight eyes were treated with diASED and 8 eyes with udASED. Baseline result on the FS was in average 5.63 for udASED and 5.25 for diASED. The FS showed improvement in 14 eyes after the first 2 weeks: eyes treated with udASED improved by 1.5 (to 4.13), and eyes with diASED by 1.38 (to 4). The results of the 2 months’ visit included 10 eyes of 5 patients. Compared to the baseline results there was a decrease by 3 (to 2.75) in the eyes treated with udASED and by 2.4 (to 3) in the eyes with diASED. After 3 months, no obvious further improvement was seen ("face"–score 2.75 in 4 eyes with udASED and 3 in 4 eyes with diASED). Objective clinical criteria did not correlate well with the FS but also improved based on an obvious reduction of corneal staining, conjunctival folds and hyperemia. Conclusions: The results provide further evidence for the beneficial effects of ASED in dry eye–syndrome. Within the first 2 weeks of treatment there was a distinct increase in subjective comfort for both diASED and udASED. This improvement continued during the first 2 months and remained stable during the last month. Although udASED showed only little numerical improvement compared to diASED, most patients preferred the use of udASED. In general, ASED was considered superior to conventional treatment for improving ocular surface health and subjective comfort.

Keywords: cornea: tears/tear film/dry eye • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • cornea: clinical science