Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study.

摘要

BACKGROUND: Owing to the improvement of modern intraocular lenses (IOLs) in terms of design and material, posterior capsule opacification (PCO) usually takes 2-3 years to develop. Thus, long term clinical evaluation of new implants is important. METHODS: As part of a prospective, non-randomised FDA trial, the Rayner Centerflex, a foldable hydrophilic acrylic, single piece IOL was implanted in one eye of 83 patients (mean age 73.5 (SD 7.0) years). Over 3 years postoperatively, a standardised FDA protocol concerning IOL safety and efficacy was followed including evaluation of spherical equivalent (SE), best corrected distance visual acuity (BCDVA), endothelial cell count (ECC), flare meter values, PCO development, and anterior capsule shrinkage. RESULTS: Postoperatively, mean SE was stable ranging between -0.3D and 0.17D. After 1-2 months, all patients achieved a BCDVA of 20/40 or better. At 3-6 months postoperatively, mean ECC decreased from 2612 (SD 346) cells/mm2 to 2380 (316) cells/mm2. Mean PCO score for the entire optic increased from 0.20 (0.20) months (3-6 months postoperatively) to 0.87 (0.57) resulting in a Nd:YAG rate of 29.41% after 3 years. No anterior capsule shrinkage was found. CONCLUSION: The Centerflex showed excellent functional results, low values for endothelial cell loss and inflammatory signs, and no anterior capsule shrinkage. PCO formation was higher compared to other IOLs, which could be explained by the incomplete sharp edge at the optic-haptic junctions representing an "Achilles' heel" for cell ingrowth.