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Evaluation of post-operative dysphotopsia and spectacle independence after bilateral multifocal IOL implantation for cataract surgery and refractive lens exchange: Acri.LISA 366D versus AcrySof SN6AD1 randomized controlled trial

Session Details

Session Title: Multifocal Technology and Comparative studies

Session Date/Time: Tuesday 08/10/2013 | 08:00-10:30

Paper Time: 10:21

Venue: Auditorium (First Floor)

First Author: : V.Maurino UK

Co Author(s): :    G. RUBIN   B. ALLAN   O. FINDL        

Abstract Details

Purpose:

To compare dysphotopsia, spectacles independence, patients satisfaction and visual outcomes after bilateral implantation of the Acri.LISA 366D and the Acrysof Restor SN6AD1 multifocal IOL in a large randomized controlled clinical trial.

Setting:

Moorfields Eye Hospital London UK, Kings’ College Hospital London UK.

Methods:

Patient and examiner masked prospective randomized controlled trial. Patients with no significant ocular co-pathology, undergoing bilateral sequential cataract surgery or bilateral sequential refractive lens exchange were randomized to either bilateral implantation with an Acri.LISA 366D multifocal IOL or an Acrysof Restor Sn6AD1 multifocal IOL. The following data were recorded at final follow-up, 4-6 months after surgery: subjective refraction; visual acuity at two luminance levels and three distances; reading acuity at patient’s preferred distance; binocular reading speed (MNRead Test); binocular contrast sensitivity (Pelli-Robson); forward light scatter (C-quant); intraoperative and post-operative complications; Patient reported outcomes were assessed with spectacle dependence, visual satisfaction, quality of vision (QoV), visual disability (Catquest-9SF) and dysphotopsia questionnaires.

Results:

Of the 188 patients recruited 169 completed the study follow up: 84 in the Acri.LISA arm (A), 85 in the Restor arm (B). Mean age was similar in both groups: 67 (SD 9.1) for A and 68 (SD9.5) for B. 60.6% of patients were female in A and 51.1% in B. Subjective Dysphotopsia was either absent or barely noticeable in 73% of group A and in 76% group B. The percentage of patients finding dysphotopsia annoying or debilitating was similar at 27.4% and 23.2% respectively. Forward light scatter was measured with the C-Quant straylight meter (Oculus Optikgeraete GmbH). The results were similar between the IOL groups (1.15 – 1.19 logS) with most subjects’ measurements falling within the normal range. Only one patient underwent exchange of multifocal IOL for a monofocal IOL because of unbearable dysphotopsia. Complete spectacles independence was reported by 82% of patients in A and 78%, in B. Overall visual satisfaction was high at 88% (A) and 94% (B). Subjective Refraction results were excellent and similar with median (IQR) spherical equivalent of 0 (-0,25/+0.25) for A and 0.13 (-0.25/+0.38) for B. Only 4 out of the 338 eyes experienced intraoperative complications, none of which lead to poor outcomes.

Conclusions:

In our large, randomized, double masked controlled clinical trial both multifocal diffractive IOLS performed well with 80% of patients being completely independent from glasses and 90% being satisfied with the final visual outcome. However, 25% of all patients did complain of dysphotosia, this was considered a serious visual handicap in 2.4% of cases. Only one patient underwent exchange of multifocal IOL for a monofocal IOL because of unbearable dysphotopsia, the latter procedure was uneventful. There were no statistically significant differences between the two IOLs in any of the outcomes measured.

Financial Interest:

... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented