Efficacy and safety of pre-operative individual topical mydriatic and anaesthetic versus an intracameral fixed-dose combination of two mydriatics and an anaesthetic for phacoemulsification – A comparative study

Abstract

Objectives: Intracameral fixed combination of mydriatic and anaesthetic is a new method for inducing and maintaining intraoperative mydriasis and analgesia during cataract surgery. The purpose of our study was to evaluate the efficacy and safety of an intracameral fixed-dose combination of phenylephrine 0.31%, tropicamide 0.02%, and lidocaine 1% during phacoemulsification in comparison to the standard pre-operative topical regimen. Materials and Methods: Fifty patients undergoing phacoemulsification were randomly divided into two groups, A and B. Surgery was performed by a single surgeon, using standard regimen in Group A and using the intracameral formulation in Group B. The outcome measures were pupil size, patient perception of pain and overall comfort, surgeon rating of overall experience, and safety. Results: Post-dilatation, the pupillary diameter was 7.7 ± 1.3 mm and 5.5 ± 1.2 mm, respectively, for Groups A and B which was statistically significant. For the perception of pain as well as overall comfort, in Group A, five patients rated 4 and 20 patients rated 5, and in Group B, two patients rated 4 and 23 rated 5. The surgeon rating for all patients of Group A was 5 but in Group B, for three patients, it was 4 because of inadequate and ill sustained mydriasis. No complications occurred in either group. Conclusion: Intracameral fixed combination of mydriatic and analgesic is safe and effective for use by experienced ophthalmologists and in uncomplicated cataract, providing a reduced pre-operative time; but because of the variable, lesser and ill sustained mydriasis, it may be avoided in complicated cataracts and by novice surgeons.