Optic Edge Design as Long-term Factor for Posterior Capsular Opacification Rates

Presented at: American Academy of Ophthalmology annual meeting, October 2004, New Orleans, Louisiana.

Received 14 November 2006; received in revised form 20 December 2007; accepted 2 January 2008. published online 05 March 2008.

Objective

To compare the difference in posterior capsular opacification (PCO) between highly refractive silicone and hydrophobic acrylic foldable intraocular lenses (IOLs) with sharp and round edge designs 3 years after in-the-bag IOL implantation in subjects undergoing bilateral cataract surgery.

Design

Open-label, prospective, randomized, multicenter clinical trial.

Participants

Two hundred and eighty-eight patients with bilateral surgery for senile cataract operated in German university clinics, eye hospitals, and private ophthalmic surgical centers (Aachen, Ahaus, Bad Hersfeld, Frankfurt/Main, Jena, Rosenheim, and Sulzbach/Saar).

Interventions

At each center, a highly refractive index silicone IOL with a sharp optic edge (CeeOn) was intraindividually compared either with a high–refractive index silicone IOL with a round optic edge (PhacoFlex) in 108 patients or with an acrylic IOL with a sharp optic edge (AcrySof) in 139 patients. All patients received standard phacoemulsification with IOL implantation in the bag in both eyes from the same surgeon. A morphological evaluation of PCO was performed by the Evaluation of the Posterior Capsule Opacification (EPCO) system 1 to 2 weeks and 11 to 14 and 35 to 37 months after surgery. The blinded digital pictures were evaluated by an independent investigator. Posterior capsular opacification was statistically evaluated by paired comparisons of 3-year cumulative incidences of neodymium:yttrium–aluminum–garnet (Nd:YAG) laser treatment and EPCO scores.

Main Outcome Measures

Posterior capsular opacification.

Results

The 3-year cumulative incidences of Nd:YAG laser capsulotomy were 2.1% (CeeOn), compared with 2.1% (AcrySof) (risk difference, 0%; 90% confidence interval, −3.4% to 3.4%), and 5.7% (CeeOn), compared with 17.0% (PhacoFlex) (risk difference, −11.4%; 90% confidence interval, −18.1% to −4.7%). In patients without Nd:YAG laser treatment, medians of the total area EPCO score were 0.0005 (CeeOn) versus 0.0440 (AcrySof) and 0 (CeeOn) versus 0.0700 (PhacoFlex) at 3 years. Functional results, safety, and handling did not significantly differ for the 3 lenses.

Conclusions

Our results suggest that modern foldable IOLs have a low incidence of PCO after 3 years. There is less PCO for sharp optic edge designs independent of IOL material.

Available online: March 5, 2008.

1 Department of Ophthalmology, Johann Wolfgang Goethe-University, Frankfurt/Main, Germany.

2 Augenzentrum Rosenheim, Rosenheim, Germany.

3 Eye Clinic Ahaus, Ahaus, Germany.

4 Department of Ophthalmology, Marienhospital Aachen, Aachen, Germany.

5 Department of Ophthalmology, Clinic Bad Hersfeld, Bad Hersfeld, Germany.

6 Department of Ophthalmology, Friedrich Schiller-University, Jena, Germany.

7 Information Sciences and Documentation, Institute of Medical Statistics, Friedrich Schiller-University, Jena, Germany.

8 Department of Ophthalmology, Bundesknappschaft's Hospital, Sulzbach, Germany.

Correspondence to Thomas Kohnen, MD, Professor of Ophthalmology, Johann Wolfgang Goethe-University, Department of Ophthalmology, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.

Manuscript no. 2006-1314.

Supported by Pharmacia, Erlangen, Germany as a clinical investigational project.

The authors have no proprietary interest in any of the devices used in the study.

Members of the research group listed in “Appendix” (available at http://aaojournal.org).

PII: S0161-6420(08)00004-3

doi:10.1016/j.ophtha.2008.01.002

11 of 46