A One Year Randomized Clinical Trial Of Topical Versus Intracameral Mydriatics In Sustaining Mydriasis During Phacoemulsification Cataract Surgery In Patients Admitted In Kle’s Dr.Prabhakar Kore Hospital And Medical Research Centre Belagavi A One Year Randomized Clinical Trial Of Topical Versus Intracameral Mydriatics In Sustaining Mydriasis During Phacoemulsification Cataract Surgery In Patients Admitted In Kle’s Dr.Prabhakar Kore Hospital And Medical Research Centre Belagavi

Abstract

Background and objectives Adequate pupillary mydriasis is a must in order to be able to perform cataract surgery either by phacoemulsification or by manual small incision cataract surgery. This is usually attained by frequent topical administration of anticholinergic and sympathomimetic mydriatic agents. In an attempt to find an alternative to this repeated eye drop instillation regimen we studied the use of an intracameral mydriatic regimen of 0.5% lignocaine and 0.001% epinephrine in initiating and maintaining the pupillary mydriasis during phacoemulsification under topical anesthesia, without any topical mydriatic or NSAID use. The objectives of our study are 1. To evaluate the safety and efficacy of an intracameral mydriatic regimen comprising of preservative free lignocaine 0.5% and epinephrine 0.001% in initiating and maintaining the pupillary mydriasis during phacoemulsification cataract surgery and to compare it with traditional preoperative topical mydriatic eye drops. 2. To evaluate perioperative circulatory side effects of intracameral epinephrine used as a component of the intracameral mydriatic regimen being used. Methodology The present study was conducted in the Department of Ophthalmology, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi to study the safety and efficacy of an intracameral mydriatic regimen comprising of preservative free lignocaine 0.5% and epinephrine 0.001% in initiating and maintaining the pupillary mydriasis during phacoemulsification in comparison with traditional preoperative topical mydriatic eye drops. To evaluate the intraoperative circulatory side effects of intracameral epinephrine used as a component of the intracameral mydriatic regimen during the period of 1stJanuary 2016 to 31st December 2016. The study was approved by the Ethical and Research Committee of Jawaharlal Nehru Medical College, Belagavi. Results The mean age in group 1 was 62.32 years and in group 2 was 60.88 years. In both groups 64% of patients were females and 36% were male. In our study the mean pupillary diameter in group 1 prior to the use of topical mydriatics was 1.74 mm with a SD of 0.29 and in group 2 prior to the use of intracameral mydriatics was 1.74 mm with a SD of 0.29. (p=1.000). After the use of topical mydriatics in group 1 the mean pupil size increased to 7.36 mm with a SD of 0.57 while in group 2 following the use of intracameral mydriatics it increased to mean pupil size of 5.92 mm with a SD of 0.64 (p<0.001). However, towards the end of surgery the pupillary diameter in group 1 was 5.82 mm with a SD of 1.05 and in group 2 it was 6.30 mm with a SD of 1.24 (p=0.147) indicative of decrease in pupillary diameter in group 1 and an increase in pupillary diameter in group 2(p<0.001). The mean pulse rate prior to the use of topical mydriatics in group 1 was 71.20 beats/min with a SD of 8.60 and prior to the use of intracameral mydriatics in group 2 was 76.24 beats/min with a SD of 13.14 (p=0.001). After the use of topical mydriatics in group 1 the mean pulse rate increased to 80.24 beats/min with a SD of 16.75 and after the use of intracameral mydriatics in group 2 was 73.88 beats/min with a SD of 10.90 (p=0.119). At the end of surgery the mean pulse rate in group 1 was 74.88 beats/min with a SD of 14.30 and in group 2 was 72.28 beats/min with a SD of 10.34 (p=0.465). The mean systolic blood pressure in group 1 prior to the use of topical mydriatics was 133.44 mmHg with a SD of 14.23 and in group 2 prior to the use of intracameral mydriatics was 146.76 mmHg with a SD of 16.48 (p=0.004). After the use of topical mydriatics in group 1 the mean systolic blood pressure was 147.40 mmHg with a SD of 17.5 and after the use of intracameral mydriatics in group 2 was 142.92 mmHg with a SD of 16.14 (p=0.346). At the end of surgery in group 1 the mean systolic blood pressure in group 1 was 138.96 mmHg with a SD of 30.78 and in group 2 was 142.00 mmHg with a SD of 13.87 (p=0.655). The mean diastolic blood pressure in group 1 prior to the use of topical mydriatics was 82.20 mmHg with SD of 9.35 and in group 2 prior to the use of intracameral mydriatics was 87 mmHg with a SD of 8.01 (p=0.095). Following the use topical mydriatics in group 1 the mean diastolic blood pressure was 85.76 mmHg with a SD of 10.14 and after the use of intracameral mydriatics in group 2 was 85.72 mmHg with a SD of 8.06 (p=1.000). At the end of surgery the mean diastolic blood pressure being 85.72 mmHg in group 1 with a SD of 10.34 and 86.04 mmHg in group 2 with a SD of 7.76 (p=0.962). Conclusions and interpretation Thus we conclude that the use of an intracameral mydriatic regimen of preservative free lignocaine 0.5% and epinephrine 0.001% constitutes a safe, rapid and effective alternative compared to the use of topical mydriatics in sustaining pupillary mydriasis in phacoemulsification cataract surgery. It has the ability to simplify the preoperative procedure done routinely, the induced mydriasis being well sustained, without significant alteration in intraoperative pulse rate and blood pressure. It is especially useful in certain subjects with a high risk for adverse outcomes like patients with cardiac disorders, hypertension, IFIS, patients with allergy to the components of a topical mydriatic regimen etc