1st and 2nd generation Bhattacharjee ring (B-HEX): multicentre trial

Session Details

Session Title: Cataract Surgery Instrumentation/Surgical Devices

Session Date/Time: Sunday 11/09/2016 | 10:30-12:00

Paper Time: 10:54

Venue: Hall C1

First Author: : S.Bhattacharjee INDIA

Co Author(s): :    B. Dick   J. Alio   K. Tjia   J. Febbraro   S. Daya   K. Reddy   S. Ganesh   A. Bhaumik Disha

Abstract Details

Purpose:

To evaluate the efficacy and safety of pupil expansion by the 1st and 2nd generation Bhattacharjee Rings (B-HEX) in a multicentre trial.

Setting:

Surgical centres in Europe and India

Methods:

Nine centres (5 Europe, 4 India) received 10 pieces 1st generation Bhattacharjee ring with instructions for use and evaluation. 5-0 Nylon device disposed in a 0.1 mm plane has notches and flanges. 23G forceps places alternate flanges above and below pupillary margin. Notches engage pupil margin. 10 pieces machine made, joint-less, 2nd generation B-HEX ring with micro-notches on flanges, evaluated in one centre. These are inserted, engaged and removed using only Lester manipulator. Preoperative and postoperative ECD, pupil size recorded. Intraoperative incision size, insertion, removal, pupil size, capsulorhexis size, stability, ease of instrumentation, Pupil shape on removal & complications evaluated.

Results:

86 eyes with preoperative pupils 6 mm or less underwent FLACS, 2.2 Phaco and Bimanual MICS with device. All evaluators found insertion and removal easy and smooth. 2 preferred square over hexagon, others had no preference. 4 commented that engaging the device required short learning curve. Satisfactory pupil expansion in all eyes except 1 FLACS eye where ring aborted for fear of extending a radial tear. 1 eye anterior flange displaced during IOL implantation and easily manipulated back. B-HEX rings with micro-notches on flanges easier to manipulate. Postoperative pupil shape and size and ECD were satisfactory. No complications noted.

Conclusions:

Implantation and explantation of the 1st generation Bhattacharjee ring with a 23 gauge forceps was easier than all available devices even through sub 1 mm incisions. Engagement was controlled but required a short learning curve but. The 2nd generation B-HEX ring was much easier to insert and remove with the Lester manipulator. The micro-notches on flanges provided excellent control during engagement of notches to the pupil margin. The ring provided safe and adequate pupil expansion which allowed easy Phacoemulsification. Commercialization of the device was recommended.

Financial Disclosure:

... gains financially from product or procedure presented