Comparative evaluation of efficacy and safety of ophthalmic viscosurgical devices in phacoemulsification [ISRCTN34957881]

Background: Various ophthalmic viscosurgical devices (OVD) are used to perform phacoemulsification and other intraocular surgeries. We performed a study to compare the efficacy and safety of three ophthalmic viscosurgical devices that are routinely used in phacoemulsification. Methods: Fifty-six patients of immature senile cataract with hard nucleus (grade 3 and 4) who underwent phacoemulsification were included. Depending upon the type of OVD, patients were randomly allocated into three groups; group 1 (n = 19), Viscoat® was used; group 2 (n = 19), Healon GV® was used; group 3 (n = 18), Healon 5® was used. Parameters evaluated were uncorrected and best corrected visual acuity, specular microscopy, intraocular pressure and pachymetry both preoperatively and postoperatively on day 1, 1 week, 1 month and 3 months and development of any complication both intraoperative and postoperative were also noted. Results: The mean increase in central corneal thickness was 15.17% (group 1); 17.26% (group 2) and 16.21% (group 3) on first postoperative day and was comparable in the three groups. The density of endothelial cells decreased postoperatively (day 1) by 12.54% (group 1), 13.76% (group 2) and 13.06% (group 3) and was comparable. The mean preoperative intraocular pressure in groups 1, 2 and 3 were 13.3 ± 2.0, 14.0 ± 2.2 and 13.2 ± 3.2 mmHg respectively, which changed to 16.0 ± 4.7, 12.2 ± 4.7 and 12.3 ± 4.8 respectively on first postoperative day and the change in intraocular pressure was significantly higher in group 1 (1 vs 2 & 1 vs 3; p = 0.02; oneway ANOVA). Conclusion: Viscoat® , Healon GV® and Healon 5® give comparable results in terms of efficacy and safety in performing phacoemulsification. © 2005 Vajpayee et al; licensee BioMed Central Ltd.