Safety and Efficacy of Current Sclera Fixation Methods for Intraocular Lenses and Literature Overview

Evaluation of the three currently most common techniques for intraocular lens (IOL) sclera fixation: (1) Prolene suture with Hoffman sclera pocket (2) four-point GoreTex suture technique (3) sutureless flanged intrascleral IOL fixation with double-needle ("Yamane") technique.

Retrospective, clinical case series (chart review) at the Department of Ophthalmology, Ludwig-Maximilians-University (LMU), Munich, Germany. Enrolled in the study were 51 patients with 55 eyes. Best-corrected visual acuity (BCVA); manifest refraction (OR); corneal tomography (central corneal thickness, CCT); biometry; central macular thickness (CMT) by optical coherence tomography (OCT); intraocular pressure (IOP); and IOL type and IOL power were recorded and compared prior to and 3 - 12 months post IOL sclera fixation surgery. Pre- and postsurgery difference analysis was performed by Wilcoxon rank sum testing (z).

Intrascleral fixation by GoreTex suture was performed in 14 (25.5%) eyes, by Prolene suture in 19 (34.5%,) and by Yamane technique in 22 (40.0%) eyes. Within the 3 - 12 months follow-up post scleral fixation, a total of 2 (14.3%) eyes from the GoreTex, 3 (15.8%) from the Prolene and 1 (4.5%) eye from the Yamane group required refixation. Pre- and post-surgery analysis revealed a statistically significant difference in the total patient population BCVA (exact Wilcoxon test: z = - 3.202; p = 0.001; n = 55) and the Yamane subgroup (exact Wilcoxon test: z = - 2.068; p = 0.001; n = 22). The GoreTex (n = 14) and Prolene (n = 19) subgroups revealed no statistically significant differences versus preoperative baseline. Across groups, there was no statistically significant difference in IOP, CMT, and CCT. No retinal complications were observed, neither intraoperatively nor during follow-up.

The volume of IOL revision surgery is increasing. Often, the only option left for visual rehabilitation is scleral IOL fixation. All three scleral fixation techniques studied demonstrated a good safety profile with no statistically significant impact on IOP, CMT, CCT, but with a notable revision rate. Visual rehabilitation to preoperative baseline levels (GoreTex [n = 14] and Prolene [n = 19]) and a statistically significant increase in visual acuity (total cohort [n = 55] and Yamane [n = 22]) seems possible. Unlike iris fixation, scleral fixation is surgically more complex and the surgeon must master a steeper learning curve.