Purpose: To assess the safety of scleral fixation using Akreos AO60 IOL and Gore-Tex suture.
Methods: Prospective evaluation of 20 patients who underwent scleral fixation of Akreos AO60 with Gore-Tex. Patients presenting with aphakia or dislocated IOL without capsular support were enrolled in the study. Main outcome measures included visual acuity, endothelial cell density, and postoperative complications over 6 months of follow-up.
Results: Mean ± SD uncorrected logMAR visual acuity improved from 1.92 ± 0.23 (20/1600 Snellen equivalent) preoperatively to 0.80 ± 0.56 (20/125) post-surgery (p < 0.001). Mean ± SD BCVA logMAR was 0.43 ± 0.23 preoperatively and 0.37 ± 0.24 (20/50) post-surgery (p = 0.312). Exposure of suture occurred in 8/20 (40%) eyes over the 6 months of follow-up. The mean ± SD endothelial cell density was 1,740.50 ± 522.92 cells/mm2 and 1,187.19 ± 493.00 cells/mm2 (p < 0.001) pre and postoperatively, respectively. Mean ± SD postoperative spherical equivalent was -1.12 ± 1.50D. Postoperative complications included hypotony in 15% of the patients, ocular hypertension and transient vitreous hemorrhage in 10%, and retinal detachment and transient lens opacification in 5%.
Conclusion: Scleral fixation with an Akreos AO60 and Gore-Tex appears safe. However, caution must be taken regarding suture exposure, and scleral flaps can be a technique to reduce the risk of this complication. Phase II studies are needed.