Visual outcomes after bilateral implantation of Versario intraocular lenses – six month follow-up


 PurposeTo study visual outcomes after implantation of Versario intraocular lenses (IOLs) Patients and MethodsIn 20 selected patients (40 eyes) uneventful, bilateral cataract surgeries with implantation of trifocal Versario (IOLs) were performed. Designprospective case series. Six months after surgery the following parameters were analysed: binocular uncorrected visual acuities (log MAR): for distance (UDVA) at 4 m, for intermediate (UIVA) at 60, 70, 80 cm and for near (UNVA) at 40 cm, photopic defocus curve, mesopic and photopic contrast sensitivities (CSs), spectacle independence, visual function test questionnaire (modified VFQ-25), subjective symptoms and postoperative complications. ResultsSix months after surgery, the mean of binocular visual acuities were as follows: UDVA: -0.12 ± 0.08; UIVA (60 cm): +0.07 ± 0.10, (70 cm): +0.05 ± 0.11, (80cm): +0.07 ± 0.09; UNVA (40cm): +0.12 ± 0.08. CSs in mesopic and scotopic conditions for distance and photopic for near were between normal range of age- match healthy control. All patients were spectacle independent. General satisfaction was high and equal 9.37±0.83. No severe glare and halo were detected. There were no postoperative complications. ConclusionsThe bimanual MICS with the Versario lenses implantation was a safe and effective method for patients who want to be spectacle independent at different distances.


Introduction
After cataract/refractive surgery, the increasing number of patients, mainly younger than 65 years old demand very good intermediate vision, as well as near vision, which is important at arm's length or longer (1). In today's world, the intermediate vision is even more crucial than near for performing daily tasks such as using mobile phones, computers and tablets. The interesting option for mentioned above patients are trifocal intraocular lenses which supply better intermediate vision in comparison with bifocals without impairing near and far visual acuity (2). Currently several trifocal diffractive IOLs are available, i.a. FineVision (PhysIOL SA), AcrySof IQ Panoptix (Alcon) (5), Acriva Reviol Tri-ED 611 (VSY Biotechnology), Versario 3F (Bausch & Lomb) and At Lisa tri (Carl Zeiss AG) (3,4,5).
Up to date, in the available literature there is only one study describing 3 months standard visual outcomes after implantation of new low addition (+3.00 diopters) Versario 3F (Bausch & Lomb) trifocal IOls (6) and the results were promising. It is known from other studies results that neuro-adaptation process lasts at least 6 months and has an important role in the improvement of visual outcomes and reduction of unwanted effects like glare and halo after implantation of multifocal IOLs (6,7,8,9,10). It was the reason why we decided to analyse six months visual outcomes, patients' satisfaction and complications after bilateral implantation of Versario 3F trifocal intraocular lenses.

Methods
The prospective study included 20 patients (40 eyes) -13 women and 7 men, patients having uneventful, bilateral, sequential cataract surgery in II Clinic of Ophthalmology in Szczecin, Poland. The patients were interested in spectacle independence and were informed about advantages and disadvantages of multifocal IOL implantation. The study adhered to the Declaration of Helsinki and was approved by the local ethics committee. Written consent was provided by all patients.
Inclusion criteria for multifocal IOLs: range of age: 55-70 years, bilateral cataract, pupil size 3 -6 mm in dim light, preoperative corneal astigmatism less than 0.75 D, hyperopic presbyopia, patients' motivation for spectacle independence, tolerant patients, willing and able to comply with scheduled visits.
Exclusion criteria: Ocular diseases other than cataract, lifestyle and job: unrealistic visual expectations, patients demanding visual precision i.e. pilots, professional drivers, architects, etc., patients satisfied with reading glasses, people over 70 years (may be difficulties with neuro-adaptation problems to new optical conditions). Personality: psychiatric disease of any type, patients unsatisfied with progressive glasses, brain stroke and dyslexia in history, type A personality (perfectionists).

Intraocular lens
Versario 3F intraocular lens (Bausch+Lomb ) is hydrophilic acrylic (25%) with hydrophobic surface trifocal IOL with 6.0 mm, diffractive, biconvex, aspheric optic, an overall diameter  Postoperatively, all patients were prescribed the eye drops of moxifloxacin, prednisolone and nepafenac for the first 4 weeks.

Statistical analysis
Quantative data are provided as means and standard deviations. The results were considered as statistically significant at p ≤ 0.05. Analysis were done using Statistics 12 software.

Results
The study group consist of 40 eyes of 20 patients. Mean age was equal 64.3± 6.4 years (range (55 to 70 years). In Table 1     There was no need for refractive lens exchange in any patient and all patients stated that they would be willing to repeat surgery with the same IOL.

Discussion
The presented visual function outcomes six months after implantation of Versario intraocular lenses (IOLs) were promising and comparable with data presented by Fernandez et al. (6).
In our study very good distance VA log MAR -0.12 was achieved after binocular implantation of Versario lenses. Obtained results were slightly better to these published by In our study binocular UNVA (logMAR 0.12) was better than in Fernandez study (logMAR 0.24) probably because of twice longer neuroadaptation time. Visual acuities of the above mentioned studies were comparable to other trifocals: AT Tisa Tri was between logMAR range of (0.11-0.22); Panoptix logMAR(0.17), Acriva Reviol logMAR (0.06), Fine Vision 0.04-0.21 (6,7,9). Analysis of spectacle independence is one of the important features describing the quality of premium IOLs. In our study all patients after implantation of Versario IOLs were spectacle independent what suggest high quality of this lens.
The frequency of patients with total spectacle independence has better result (100%) than all 3 other IOLs (89%, 90%, and 86% in the Pan Optix, Fine Vision, and Symfony groups, respectively) (13). Overall 86 to 90% spectacle independence achieved. We think that total spectacle independence was obtained thanks to precise selection of the patients for this type of IOL.
Second cause of total spectacle independence is precise power calculation. All patients were postoperative refractive errors were no more than +/-0.5 D. 8 The last explantation is small number of patients included in our study.
The next important parameter describing VA of premium IOL is analysis of visual function quastionnare. Nowadays it is very difficult to compare data from VF other study, because there is no international standards describing quality of vision VF questionnaire.
In our study a modified VFQ 25 test was used. General satisfaction was very high equal to 95 %, in line with Fernando study (6). Halos, glare and difficulty in night time driving are side effects of patients with MIOLs. In majority of patients photopic disturbances were decreased with time and don't impact their lives. This phenomenon has been termed as neuroadaptation, wherein patients require a certain postoperative period to adjust to the retinal images and this is frequently observed with MIOLs. Versario lens was comparable to different trifocal IOLs. It can be classified as a trifocal EDOF IOL because of the performance between extended depth of focus IOLs and medium-high addition trifocal IOLs (6).

Conclusion
The bimanual MICS with the Versario lenses implantation was a safe and effective method for patients who want to be spectacle independent at different distances. Comparison of visual outcomes after implantation of Versario lens with other trifocal IOLs permit to connclude that such lenses can be offerred and proposed equally with other multifocal lenses in patients who want to be spectacle independent.