Long-term centration and incidence of PCO of an acrylic MICS IOL

Session Details

Session Title: PCO. Cataract Surgery Complications/Management

Session Date/Time: Tuesday 08/09/2015 | 08:00-10:30

Paper Time: 08:18

Venue: Room 1

First Author: : B.Johansson SWEDEN

Co Author(s): :    B. Dick   G. Lesieur   J. Alio   S. Morselli           

Abstract Details

Purpose:

To evaluate the long-term centration and incidence of PCO of a micro-incision intra-ocular lens (IOL) comprising a new acrylic material with 22% water content (Incise® IOL, Bausch + Lomb). The lens is designed with an aberration-free aspheric optic and a 360° posterior sharp square edge measured to 5µm radius.

Setting:

5 European centers, prospective ethics committee approved clinical study. St Erik Eye Hospital, Stockholm, Sweden Inköping University Hospital, Swedan University of Bochum, Germany Centre Ophthalmologique Iridis, Albi, France Vissum Institute, Alicante, Spain Ophtalmic Unit, Hospital of Bassano del Grappa, Italy

Methods:

The Incise IOL was implanted in 103 eyes with the Viscoject 1.5 BIO inserter. 1.8mm in the bag or 1.4mm wound assist implantation techniques were used. In Phase I UDVA, CDVA, manifest refraction and refraction predictability were measured 4-6 months (M) postoperatively. In Phase II, digital slit lamp photographies of implanted IOLs were obtained 12, 18 and 24M postoperatively. To determine IOL centration, the centre of 2 ovals were overlaid to circumscribe the IOL optic edge and the limbus respectively, and were compared. PCO was assessed using the EPCO score (within the rhexis and 3 mm central areas were scored).

Results:

101 eyes completed Phase I: At 6 months post-op, mean CDVA was -0.02 ±0.09 logMAR (20/20) with 97.0% of eyes with 20/25 or better. Mean absolute predictive error was 0.44 ±0.38 with 90.4 % of eyes within 1.00D of the intended refraction. The IOL centered in a superior nasal position with an absolute mean centration of 0.27±0.13 mm, 0.28±0.16 mm, and 0.31±0.15 mm at 6M (n=98), 12M (n=92) and 18M (n=78), respectively. EPCO score within the rhexis area was 0.00±0.02, 0.01±0.6, and 0.04±0.6 at 6M (n=97), 12M (n=91) and 18M (n=78), respectively.

Conclusions:

The Incise MICS IOL demonstrated predictable and stable centration up to 18 months after implantation. Its enhanced edge profile appears to be effective in preventing PCO with a very low EPCO score at 18M. 24M visit data will be available at the time of the presentation.

Financial Interest:

One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One of the authors travel has been funded, fully or partially, by a competing company, One of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors research is funded, fully or partially, by a competing company, One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors receives consulting fees, retainer, or contract payments from a competing company