Evaluation of Stability and Capsular Bag Opacification of New Foldable Adjustable IOL
Purpose
To evaluate the stability, as well as uveal and capsular biocompatibility of a new hydrophobic acrylic modular intraocular lens (IOL) in the rabbit model. The test lens was composed of 2 separate pieces; a base component and an optic. This design facilitates atraumatic post op optic exchange if needed.
Methods
Bilateral phacoemulsification was performed on 6 rabbits; one eye received the test IOL (HARMONI Modular Intraocular Lens System, ClarVista Medical), while the other eye received a commercially available single-piece hydrophobic acrylic control lens (SA60AT, Alcon). Slit lamp examinations were performed at postoperative weeks 1, 2, 3, 4, and 6. All rabbits were sacrificed at postoperative week 6. After enucleation, the rabbit eyes were examined grossly from the Miyake-Apple view. Following, all globes were sectioned and processed for histopathologic examination.
Results
The modular IOL was found to be stable in all 6 rabbits. Uveal biocompatibility was similar to or better in the test eyes when compared with control eyes up to 6 weeks postoperatively. Overall capsular bag opacification was found to be significantly lower in the test eyes when compared with the control eyes. At the 6 week gross examination, central posterior capsule opacification (PCO) was scored as 0.58 +/- 0.73 in the test group, and as 3.00 +/- 1.26 in the control group (Paired Two Sample for Means T-Test; Two-tail P= 0.005).
Conclusion
The HARMONI Modular IOL System remained stable and biocompatible within the capsular bag after implantation. In addition, due to the design of the base component featuring long haptic loops along with peripheral anterior and posterior square edges, the IOL appeared to prevent overall capsular bag opacification in the rabbit model.