Evaluation of a new scleral fixation foldable IOL in the absence of capsule support

The purpose of this study was to compare a new scleral fixation foldable intraocular lens (IOL), the Ophtec PC 425Y 6/13.5, with the scleral fixation rigid IOL Alcon CZ 70 BD, as regards efficacy, surgical complications, advantages, disadvantages, and surgery costs in cases with no capsule support.

This was a retrospective study conducted on 24 patients (24 eyes), 14 of whom had traumatic cataract, six had postphacoemulsification complications, two were aphakic, and two had lens luxation. The patients were divided into two groups: group l, scleral fixation foldable IOL, and group ll, scleral fixation rigid IOL, made up of 12 patients each, during a study period lasting 20 months. The procedures were performed under topical plus subconjunctival anesthesia in group l, under general anesthesia in group ll, all by the same surgeon. The IOL scleral fixation technique used in both groups was the scleral incision technique.

The mean age of group I patients was 57.8 years (range, 24-75 years), and in group II patients 50.3 years (range, 7-75 years). The average duration of the surgical intervention was significantly lower in the group I: 32.5 min (+/-0.19) versus 43.4 min (+/-0.4.2) in the group II (p<0,001). The incision required for the Ophtec PC 425Y 6/13.5 foldable intraocular lens was less than half the length needed for the other rigid intraocular lens (3.2 mm versus 7.0 mm). In group I, the patients reported no discomfort intraoperatively or postoperatively, and none required intravenous sedation. The mean duration of the convalescence period showed a statistically significant difference between the two groups: 3.8 (+/-0.45) weeks for group I and 12.5 (+/-0.90) weeks for group II (p<0.001). Group I achieved a Best optical Correction Visual Acuity (BCVA) of 0.57 (+/-0.17) at the 1st week postoperatively, whereas group II achieved a BCVA of 0.44 (+/-0.19). The difference was statistically significant (p<0.05). In the 1st postoperative month, group I presented a mean postoperative astigmatism of -0.88 D (+/-0.42) and group II presented a mean postoperative astigmatism of -2.42 D (+/-0.60). The difference was statistically significant (p<0.05).

In this study, the scleral fixation of the foldable IOL Ophtec PC 425Y 6/13.5 with the scleral incision technique took less time, needed a smaller incision and provided a better visual outcome, suggesting that this could be the alternative to the conventional scleral fixation rigid IOL.