A novel intraocular lens designed for sutureless scleral fixation: surgical series.

PURPOSE: To report a retrospective series of patients implanted with a novel hydrophilic acrylic single-piece intraocular lens (IOL) designed for sutureless scleral fixation (FIL-SSF Carlevale lens, Soleko, Italy) injectable through a 2.2-mm incision. METHODS: Seventy-eight patients with minimum 6-month follow-up were divided into 6 groups: dropped nucleus, luxated IOL, trauma, aphakia, IOL exchange, and Marfan's syndrome. Surgery included peritomy and scleral flap creation at 3 and 9 o'clock position. The IOL was then injected and grasped with 25G forceps through a hole created 2 mm posterior to the limbus underneath the sculped scleral flap. RESULTS: The study included 78 patients (mean age 71.9 ± 12.6 years) and average follow-up 10.2 ± 4.2 months. Average surgery duration was 69.4 ± 26.1 min and vision significantly improved from 0.86 ± 0.56 logMAR to 0.38 ± 0.42 logMAR at 6 months post-operative (p < 0.001). Intraoperative complications included corneal edema, retinal tears, and vitreous bleeding each in 2/78 patients (2.5%); 1/78 (1.3%) localized retinal detachment and 1/78 (1.3%) rupture of one T-shaped IOL harpoon. Post-operative complications included 4/78 (5.1%) cystoid macular edemas, 2/78 retinal tears, 2/78 retinal detachments, 2/78 developed ocular hypertension, and 1/78 corneal decompensation requiring DSAEK. CONCLUSION: The Carlevale lens is designed for sutureless intrascleral fixation and can be successfully used in a variety of indications including difficult trauma cases with good rehabilitation. An implant requires experience and delicate manipulation.

Accuracy of IOL Power Calculation Using the New Carlevale Sutureless Scleral Fixation Posterior Chamber IOL.

PURPOSE: To evaluate the refractive outcomes of the new Carlevale foldable sutureless scleral fixation intraocular lens (SSF-IOL) (Soleko in eyes without capsular support. METHODS: This retrospective, single-center, noncomparative interventional case series included 25 consecutive eyes of 25 consecutive patients with either aphakia or lens/IOL dislocation due to capsular or zonular defects. The Hoffer Q, Holladay 1, and SRK/T formulas, which do not need measurements of the anterior chamber depth to predict the IOL position, were used to calculate the IOL power. Constant optimization was performed to zero out the mean prediction error (PE). The main outcome measures were mean PE ± standard deviation, median absolute error (MedAE), mean absolute error (MAE), and percentage of eyes with a PE within ±0.50 and ±1.00 diopters (D). RESULTS: Mean axial length was 24.09 ± 2.09 mm (range: 21.85 to 32.17 mm). No statistically significant differences were found among the three formulas for any parameter. The PE was zero due to constant optimization and its standard deviation ranged between 0.89 and 0.95 D. The MedAE ranged between 0.30 and 0.34 D, whereas the MAE ranged between 0.62 and 0.67 D. The percentage of eyes with a PE within ±0.50 D was between 56% and 64% and the percentage of eyes with a PE within ±1.00 D was between 69% and 72%. CONCLUSIONS: Reasonably good refractive outcomes can be obtained when implanting SSF-IOLs in eyes with no capsular support, although the accuracy is lower than what is reported for normal in-the-bag IOL implantation. [J Refract Surg. 2021;37(7):472-476.].

Long-term Outcomes and Complications of the New Carlevale Sutureless Scleral Fixation Posterior Chamber IOL.

PURPOSE: To evaluate the visual outcomes and possible complications of a new foldable sutureless scleral fixation intraocular lens (SSF-IOL), the Carlevale IOL (Soleko). METHODS: The SSF-IOL, which has two T-shaped self-blocking plugs on each haptic, was inserted into the posterior chamber. Both haptics was grabbed through two sclerotomies and the two short arms were blocked under the scleral flap, without any suture. A complete clinical evaluation was done preoperatively and at 3, 6, and 12 months postoperatively. RESULTS: A total of 54 eyes of 50 consecutive patients were retrospectively analyzed. The mean corrected distance visual acuity was 0.93 ± 0.61 logMAR preoperatively and improved to 0.42 ± 0.34 logMAR at 3 months, 0.42 ± 0.37 logMAR at 6 months, and 0.38 ± 0.38 logMAR at 12 months postoperatively (all P < .0001). The mean corneal endothelial cell density decreased from 1,725.37 ± 528.06 to 1,612.81 ± 522.91 cells/mm2 at 12 months postoperatively (P < .0001). The mean IOL tilt value was 3.1 ± 1.1° at 12 months postoperatively. The authors observed 6 cases (11.1%) of intraoperative rupture of the IOL haptics, 4 cases (7.4%) of early hyphema, 4 cases (7.4%) of macular cystoid edema, 2 cases (3.7%) of haptic exposure under the conjunctiva, and 1 (1.8%) late retinal detachment. CONCLUSIONS: This newly introduced surgical technique provided promising results regarding efficacy and safety. Complications occurred in a few cases and were successfully managed. The Carlevale IOL seems to be a surgical solution combining the advantages of an easy and minimally invasive implantation with a good functional recovery with minimal complications. [J Refract Surg. 2021;37(2):126-132.].