Evaluation of Stability and Capsular Bag Opacification With Foldable IOL Coupled to Protective Membrane in Rabbit Model

Saturday, April 18, 2015: 3:44 PM
Room 5A (San Diego Convention Center)
Gregory D. Kramer, MD
Kyle MacLean, MD
Mohammed A. Farukhi, MD
Gareth Lance Gardiner, BS
Liliana Werner, MD, PhD
Nick Mamalis, MD

Purpose
Evaluating stability and capsular bag opacification of a silicone protective membrane (PM) implanted into the bag with secondary placement of an intraocular lens (IOL).  A pattern on the posterior surface of the PM to enhance prevention of postoperative capsular opacification compared to a smooth PM and control IOL was assessed.

Methods
The eyes of twelve New Zealand rabbits were implanted with a PM and an IOL, or an IOL alone.  Eight of the rabbit eyes received the IOL implant and the smooth PM implant, the IOL implant and the Sharklet patterned PM implant, or the IOL alone.  Eyes were evaluated by slit lamp examination and scored for ocular inflammatory response at weekly intervals for 4 weeks postoperatively.  At postoperative week 4, the rabbits were humanely sacrificed, and their globes were enucleated.  Capsular bag opacification was scored from the posterior aspect (Miyake-Apple view), and the eyes were processed for complete histopathologic examination.

Results
At 4 weeks, central posterior capsule opacification (PCO) was 0.28 +/- 0.32 in all eyes with a PM, and 2.08 +/- 1.28 in eyes with the IOL alone (P ˂ 0.00001; T-Test).  Peripheral PCO and Soemmering’s ring formation were also significantly less in eyes receiving the PM.  Histopathologically, the posterior capsules were relatively clear in the majority of the IOLs with the PM in place.  Both smooth and patterned PM devices showed a significant difference in PCO, ACO, and Soemmering's ring formation compared to the IOLs without the PM.

Conclusion
The bulky nature of the PM leads to significant expansion of the capsular bag and appears to prevent capsular bag opacification.  Further studies are warranted to assess whether the pattern on the device’s posterior surface further enhances this preventative effect.