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Taken into consideration that refractive surgery involves healthy eyes, it is clear that patients´ expectations are among the highest and patient reported outcomes are particularly important. A few investigations about the performance of the diffractive trifocal implant studied involved either cataract surgeries or mixed groups (cataract and refractive procedures).
The aim of current work was to collect and evaluate real-life data from various refractive clinics of the SMILE EYES group after a pure refractive lens exchange (RLE) using one single brand of a trifocal intraocular lens (AT LISA® tri, Carl Zeiss Meditec AG, Germany). The data consisted of patient satisfaction, the ability to perform different activities, spectacle independence and complaints following the procedure, reasons and information sources for the given surgery as well as objective data such as patient age, sex, pre- and postoperative visual acuity (VA) as well as refraction and complications.
Results: 146 patients were invited to participate in the study. The response rate was 70.5%. Data of 102 patients (45 males, 57 females) or 204 eyes respectively was included in the analysis. The mean age was 54.6 ± 5.2 years (Min.: 42, Max.: 58). The mean preoperative refraction was 0.93 ± 2.17 with an axial length of 23.35 ± 1.17 mm (Min.: 20.96; Max.: 28.36). 172 eyes were hyperopic (spherical equivalent (SE) >0 D), 25 were myopic (SE<0 D) and 3 eyes were emmetropic (SE=0 D). The postoperative refraction showed a mean SE of -0.29 ± 0.53 D (Min.: -2.13 D; Max.: +1.5 D). Pre- and postoperative decimal VA were found to be comparable, prior to surgery: 0.99 ± 0.21 D (Min.: 0.2; Max.: 1.25); post surgery: 0.98 ± 0.16 D (Min.: 0.25; Max. 1.25). 73.04% of the patients were within ± 0.5 D of the refractive target.
83 patients (82.2%) reported their expectations to be fully fulfilled, 18 (17.8%) stated that these were partially fulfilled. Accordingly, 91 (92.9%) patients would recommend the procedure to a close friend. 58% of the patients consider the surgery to be expensive.
A significant improvement of self reported visual acuity could be observed in all investigated areas.
The questionnaire also evaluated the remaining complaints when answering the quationnaire. The vast majority of complaints was due to the photic phenomena, such as starbursts. Blurry vision, itchiness, distorted vision or tearing were less common.
In general, the amount of vision related postoperative limitation was reported as low, with 96 of 102 Patients (94.1%) reporting no limitations in performing daily activities, and 99 of 102 Patients (97%) – no limitations with leisure and sports activities. The most common limitation involved driving (77.5%) – both at night and in conditions of poor visibility (68.6%).
Postoperatively 61.1% of the patients require no spectacle correction at all. Those requiring correction needed it mostly for near (31.7%), less frequently for intermediate tasks (15.8%) and for distant vision (5%) respectively.
The (corrected) capsulotomy rate was 18.8%. 7% of patients required a laser touch-up due to residual refractive error. 3% of patients presented with pseudophacic cystoid macular oedema.
The most common reason to undergo a refractive procedure was the wish to achieve a higher quality of life. Media and social contacts were the main sources of information about the surgical procedure.
Discussion: Other relevant studies involving cataract patients and mixed patient groups (cataract and refractive) demonstrated similar patient satisfaction with the multifocal lens studied. The rate of patients meeting the refractive target was also comparable. Photic phenomena proved to be a relevant postoperative problem, and driving at night – a challenging task. The spectacle dependence, especially at near, was higher than in other studies, although these showed variable results. The complication rates were not higher than in other studies.
Conclusions: The real-life data from a purely refractive cohort using one single brand of a trifocal IOL shows high patient satisfaction and good refractive results. However, the disturbing photic phenomena particularly when driving in poor light conditions and the eventual necessity to use a visual aid, especially at near remain the drawbacks of a diffractive trifocal design limiting the number of potential candidates.