Abstract
Purpose :
The aim of this study is to compare the ECL induced by two different cataract surgical techniques, the endocapsular gold standard technique Divide & Conquer (D&C) and a supracapsular technique less described in literature the Subluxation (Sub); according to the hardness of the lens.
Methods :
The PERCEPOLIS study was a randomized clinical trial, in routine care, comparative, in two parallel groups, carried out from June 2015 to April 2016. Our actual study is an ancillary study, analyzed in superiority. It compared the two surgical techniques according to the hardness of the lens. During the first consultation we classified the lens hardness into 3 subgroups, from soft N1 to hard N3. Pre- and postoperative specular counts were performed by non-contact specular microscopy (Nidek CEM-530). The primary endpoint was postoperative ECL at 3 months and at 12 months. The secondary endpoints were surgical time and the occurrence of complications during the surgery.
Results :
The analysis involved 285 eyes. The subgroups of nuclei included respectively (Sub vs D&C): N1 (27 vs 21), N2 (71 vs 71), N3 (43 vs 52) patients. Populations in each subgroup showed no difference in age or sex. Regarding the primary endpoint, Endothelial Cell Loss at 12 months, the results showed no superiority in any subgroup. Subgroup N1: -8% (SD 7)Sub vs -13%(SD 16) D&C p=0.25 along with Subgroup N2: -15% (SD 14) Sub vs -10% (SD 10) D&C p=0.44 and Subgroup N3: -16% (SD 12) Sub vs -14% (SD 15) D&C p=0.74. The technique (Sub) significantly reduced the operating time (min:s) in each subgroup with Sugroup N1 : 4:53 (SD 0:40) Sub vs 5:52(SD 0:43) D&C p<0.001 and Subgroup N2 : 5:00(SD 1:02) Sub vs 6:31(SD 2:42 ) D&C p<0.001 and Subgroup N3 : 6:00 (SD 1:27) Sub vs 6:28 (SD 1:39) D&C p=0.01.
Conclusions :
This ancillary study does not establish the superiority of the subluxation technique concerning the Endothelial Cell Loss after 3 months and 12 months, whatever the hardness of the nucleus. However, the analysis on subgroup reduced the power of our study. Despite of this, our result seems to show a clear superiority of the subluxation technique on the reduction of operative time, especially when the lens hardness are soft or mild.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.