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SUSSEX, UK - Excellent fixation and centration: these are the two main findings of the initial six months of the German Centerflex study.
The German study, part of a larger European study, has recruited 84 patients (54 women and 30 men) so far. The mean age of participants was 73, but the range is wide (30 to 86 years).

Gerd Auffarth MD, University of Heidelberg reviewed the preliminary data from these patients, with follow-up ranging from two to 12 months.
Patients received Centerflex IOLs of between 14 D and 30 D. Preoperative visual acuity varied between 0.05 D to 0.8 D. The mean endothelial cell count was 2614 (+/- 384).

Visual acquity
All patients studied achieved visual acuities of better than 0.5 D (or 20/40) at 6 months and development of distance visual acuity was progressive.
From an average of less than 0.4 D preoperatively, the mean stabilised around 0.8 D between three and six months. For the 34 patients for whom one year follow-up is available, distance visual acuity was maintained at the level achieved by the six-month period. All patients achieved a corrected distance acuity of 20/40 or better after six months.

The corneal endothelial cell count did not change significantly over the study period: values oscillated close to the baseline levels over measurements at one day, two months and six months postoperatively.

Dr Auffarth noted that on top of the usual FDA safety and efficacy examinations, the investigators looked very carefully at centration, IOL rotation and PCO development. These were the areas in which it was felt the new lens provides the most benefit over existing implants.

The researchers measured the area of overlap between the capsulorrhexis and the entire optic in order to assess the stability of the lens. They used a custom computer-based system of immunoanalysis. The results showed a very stable anterior capsule over the lens, he said.

The same program was used to measure rotation of the lens within the capsule. The computer takes a reference point, for example a haptic, and then monitors the position of the lens at several time points. The rotation changes of the lens detected were very small, under 3o over a period of six months. Only one patient had a significant rotation of 30o in the first week.

"We used a similar system to measure centration. The displacement of the centre of the optic was followed over time. We found very little movement: the maximum was 0.85 mm (found at one month post-operatively), and the average over six months was 0.5 mm. The biggest changes both in centration and rotation were observed within the first four weeks," Dr Auffarth explained.

EPCO for evaluation of PCO
He and his colleagues used a computer system called EPCO for evaluation of posterior capsule opacification (PCO). The system calculates a PCO index for each lens studied. The computer first measures the area of the lens affected by opacification. It then assesses the degree of opacification according to a gradient and uses the two elements to calculate the PCO index at several observation points. That PCO score can be compared over time and between different lenses.

"It is very early days to make accurate assessments of PCO with Centerflex, but we have done some initial comparisons with a large database of PCO in different lenses in our centre.

"I can say that, so far, Centerflex is scoring at six months at the same level that rounded edged silicone and Acrysof lenses do at 12 or 14 months," Dr Auffarth observed.

He added that his experience with Centerflex so far had been very positive, citing such advantages as easy and safe implantation, excellent centration and fixation and very little rotation. Furthermore, its biocompatibility is good and the refractive power is reliable.

In the long-term, however, he said PCO could prove problematic.

Dr Auffarth presented his findings at a symposium sponsored by Rayner held in Buxted Park, Surrey, UK.

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