Efficacy and safety of intracameral administration of a fixed combination of mydriatics and anesthetics during cataract surgery in type II diabetic patients

Session Details

Session Title: Presented Poster Session: Equipment, Instrumentation & Surgical Devices

Venue: Poster Village: Pod 1

First Author: : M.Labetoulle FRANCE

Co Author(s): :                           

Abstract Details

Purpose:

To evaluate the efficacy and safety of ICMA (intracameral combination of two mydriatics and one anaesthetic; Mydrane®) for cataract surgery in a subgroup of type II diabetic patients.

Setting:

Subgroup analysis of a multicentre, international Phase III study.

Methods:

The results of 57 patients (9.7% of all patients) with diabetes mellitus (controlled, non-insulin dependent) and undergoing phacoemulsification with intraocular lens (IOL) implantation who had been included in the phase III, prospective, randomised, controlled study were analysed. The selected eye received either ICMA (ICMA group, n=25) just after the first incision during cataract surgery or standard mydriatic eye drops (tropicamide 0.5% and phenylephrine 10%; ED group, n=32) preoperatively; 3 drops of each drugs. The primary efficacy variable was the achievement of capsulorhexis without additional mydriatics. Other outcome measures included pupil size, intraoperative ocular discomfort, and safety.

Results:

Capsulorhexis was successfully performed without any other mydriatic treatment for 96.0% of diabetic patients in the ICMA Group vs 89.7% in the ED Group. From the beginning of capsulorhexis, the mean pupil diameter was >7 mm for diabetic patients in both groups. Pupil size changed less than 1 mm from just before capsulorhexis to the end of surgery in 82.6% of diabetic patients in the ICMA group vs 24.0% in the ED group. Pupil dynamics in diabetics were comparable to those observed in non-diabetics. Ocular discomfort and safety data were similar between groups.

Conclusions:

ICMA is an effective and safe alternative to standard mydriatic eye drops for initiating and maintaining intraoperative mydriasis during cataract surgery in type II diabetic patients.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company