In-the-bag Implantation of the PhacoFlex SI-30 Highrefractive Silicone Lens Through Self-sealing Sclerocorneal and Clear Corneal Incisions

Abstract

Objective: Performance of a new foldable open-loop silicone lens when implanted through a small incision into a rhexis bag. Study Design: Prospective study with a mean follow-up of 5.9+/-1.6 months, minimum 3 months. Setting: First University Eye Hospital, Vienna. Patients: 35 patients each received the implant through a 3.2 mm superior sclerocorneal or a 3.0 mm temporal clear corneal self-sealing tunnel incision, using two types of implantation forceps. Main Outcome Measures: Manoeuvrability, ease of implantation, capsular bag residence, optic-iris clearance, biocompatibility, visual acuity, keratometry, computerized corneal topography. Results: Excellent control of folding and insertion, good centration with round, well-centered 4–5 mm capsulorhexis opening, visual acuity = >20/30 in all and = >20/25 in 95% of best cases, corneal shape essentially unaltered; four minor (5.7%) and two moderate decentrations (2.90/0) due to an improperly shaped rhexis and/or an optic-edge-by-rhexis capture, four cases (5.7%) of partial buttonholing of optic through adequately shaped rhexis; bluish tint and granularity of silicone optic a regular but clinically insignificant observation. Conclusions: PhacoFlex SI-30 lens meets criteria for real small-incision, including sutureless clear corneal cataract surgery. Enhanced loop rigidity may optimize intraocular performance.