Aim: This research was conducted to determine whether or not a recently formulated intraocular lens (IOL) with an extended depth of focus (EDOF) successfully treats cataracts. Different Techniques: After performing phacoemulsification cataract surgery on a total of 36 eyes belonging to 25 patients ranging in age from 51 to 82, the LUCIDIS EDOF IOL, which was produced by SAV-IOL SA and is situated at Route des Falaises 74 in Neuchatel, Switzerland, was successfully implanted. The patients’ ages ranged from 51 to 82. SAV-IOL SA, located at 74 Route des Falaises in Neuchatel, Switzerland, served as the location for the surgical procedure. Switzerland is home to the city in question. During the course of the three-month follow-up period, the patients’ uncorrected near vision (UNVA), distance-corrected near vision (DCNVA), uncorrected and corrected distance vision (UDVA and CDVA), monocular defocus curves, and refractive outcomes were evaluated. Result: “The postoperative mean values for UDVA, UNVA, and DCNVA were 0.10 0.19, 0.16 0.24, and 0.39 0.38, respectively. The average distance-corrected visual acuity was over 0.30 between +1.02 and 1.52 D defocus. After cataract surgery, the Synthesis + EDOF IOL provides functional far, intermediate, and close vision. A micro-monovision method might boost this new IOL’s near-visual performance. Clinical investigations should confirm this pilot study’s findings.
Significant progress has been made recently in the study and creation of intraocular lenses (IOLs) that can treat presbyopia [1, 2]. Intraocular lenses (IOLs) with an enhanced depth of focus have been more widespread recently as a presbyopia therapy [3, 4]. Extending light around a single focal point, these intraocular lenses (IOLs), surgically implanted into the eye, aim to increase the depth of focus and the field of view. Presbyopic people may thus require the usage of corrective lenses to see clearly at a variety of distances [4]. The employment of a pinhole design [5], the generation of controlled levels of spherical aberration [6], the blending of refractive and diffractive surfaces to increase achromatic and chromatic aberrations [7, 5], or any combination of the techniques above may all be used to achieve this. Alternatively, a pinhole design can achieve this [5].
The results of the various EDOF IOLs that are now on the market have been the subject of several studies up to this time. These investigations have been conducted up to now. These studies [1, 2, 3, 4, 5, 6, 7] have produced data showing the therapeutic efficacy of numerous IOL models and the visual rehabilitation offered. Although there is no difference between the EDOF IOL models in terms of recovering vision at intermediate distances, there is a significant amount of heterogeneity in the degree to which near vision may be returned [8, 9, 10, 11, 12]. An innovative way to treat presbyopia is the EDOF technique, also known as LUCIDIS EDOF IOL (SAV-IOL SA, which may be located at Route des Falaises 74, Neuchatel, Switzerland). This approach uses primary and secondary spherical aberrations and a transition zone. A mono-focal periphery at the edge of the image is the end consequence of this zone. This new design should be able to shield against glare, starbursts, and other light disturbances. Additionally, it should maintain a sufficient level of near vision while providing continuous high-contrast vision from a distance to an intermediate vision.
Achieving this goal does not necessitate compromising your capacity for detailed perception. Two additional objectives include upholding ocular optical quality and safeguarding advantageous near vision. Nevertheless, comprehensive research articles detailing the outcomes of clinical studies employing the novel EDOF IOL model have yet to be released. This particular clinical trial delved into assessing both long and short-range vision. It evaluated the binocular defocus curve and refractive predictability of post-cataract surgery eyes equipped with the Synthesis EDOF IOL implant. The study was conducted by a team of researchers affiliated with the University of California, San Francisco.
In this pilot case series, simple phacoemulsification cataract surgery was carried out on a total of 36 eyes belonging to 25 patients using the EDOF IOL (LUCIDIS EDOF IOL, SAV-IOL SA, Route des Falaises 74, Neuchatel, Switzerland). The EDOF IOL (LUCIDIS EDOF IOL, SAV-IOL SA, Route des Falaises 74, Neuchatel, Switzerland) was employed during the process. Every single victim was a citizen of Switzerland. During their preoperative appointment, every patient was given the proper research information, and their agreement to participate in the study was obtained in line with the Declaration of Helsinki. The institution’s ethics committee approved the study project.
Patients with cataracts, presbyopia, or presbyopic astigmatism who wish to avoid wearing glasses were required to have a projected post-operative astigmatism of 1.02 diopters or less to be eligible for the experiment. Patients with presbyopia with astigmatism were not required to do this. For some reasons, including past ocular surgery, current or systemic ocular illness, corneal astigmatism, iris abnormalities, and a family history of glaucoma, uveitis, or retinal issues, participants were rejected from the study. All of the patients underwent thorough preoperative ophthalmological exams, which included, among other things, manifest refraction, infrared pupillometry, indirect ophthalmoscopy, corneal topography and pachymetry, slit-lamp examination, Goldmann applanation tonometry, optical biometry and keratometry (LENSTAR, Switzerland), and other tests. In addition to those times, every patient was examined the day following surgery, one month after, and three months after. Tonometry, a biomicroscopic evaluation of anterior segment integrity, assessments of monocular uncorrected distance and near visual acuity (respectively at 40 cm), and a thorough eye examination were all performed on the postoperative day. Patients who underwent surgery underwent a comprehensive eye examination three months after therapy. Slit-lamp biomicroscopic examination, manifest refraction, measurement of the monocular CDVA and DCNVA, and evaluation of the defocus curve in one eye are all included in this test. This exam was designed to determine the patient’s functional recovery level. The patient had these procedures to have their functional abilities assessed. When the patient wore the sphere cylindrical refraction that provided them with the clearest distance vision, their defocus curve was documented using five-meter Snellen charts. Their visual acuity was measured before and after the patients received defocus in increments of 0.5 D, ranging from +0.52 D to -3.52 D. Once the data had been acquired, it was shown as a Cartesian graph, with the y-axis denoting the highest visual acuity and the x-axis representing the degrees of defocus.
The same highly competent surgeon used the sutureless microincision phacoemulsification technique to complete each procedure. After giving mydriatic drops and local anaesthetic, the doctor began the procedure by making a surgical incision in the cornea’s temporal region. Finally, the corneal flap started to form on its own. The creation of a manual capsulorhexis followed phacoemulsification. The intraocular lens (IOL) was then placed into the capsular bag through the primary incision using a 2.8-millimetre injector given by the business.
After the surgery, the patient was given an antibiotic and steroid cream to apply to the wound on a four-by-four schedule for seven days. The length of the extended depth of focus (EDOF) intraocular lens (IOL), a one-piece device, depends on how much power it contains. A 6.0-millimeter aspheric optic is also available. It includes four-point fixation haptics and a 360-degree continuous square posterior optic border. It has also been changed to improve the adherence of the zero-degree capsular bag. It is constructed of hydrophilic acrylic with a 1.459 refractive index.
A unique transition zone links the extended depth of field (EDOF) core zone of intraocular lenses (IOLs) to the mono-focal optical periphery. The area produces primary and secondary spherical aberrations with opposing signs, enhancing the field depth. The maker of this IOL concluded that the A-constant should have a value of 118.0. The power of the IOL was calculated in this investigation using the Barrett Universal II (BU-II) formula. The calculations assumed that the dominant eye would have an emmetropia refractive defect and the non-dominant eye would have a modest degree of myopia, around 0.50 diopters.
The data was collected using a spreadsheet that had been created in Excel. An analysis of variance (ANOVA) was carried out to investigate the differences between the datasets the three groups produced. Using SPSS 20.0, we could ascertain that the required level of statistical significance was p 0.05.
The participants in this study ranged in age from 51 to 82 years old when they turned over their eyes for examination, submitting 36 eyeballs. Each of the eight patients had their IOL implanted in one eye at a time. Eleven of the 18 patients who were going to have bilateral intraocular lens implants as part of the procedure had symmetric goal refraction in mind before the procedure was carried out. In contrast, a micro-monovision method was developed and used on 8 out of the 9 eyes of patients who had myopia of at least 0.50 D. The sample included 11 men and 14 women in total. There were eleven ladies in all. The observed axial lengths lay between 22.05 mm and 26.28 mm, with an average axial length of 23.98 mm and a standard variation of 1.34 mm. The axial length was 23.78 millimetres long on average. The range ranged from 39.02 mm to 46.18 mm, while the keratometry readings ranged from 42.21 diopters to 42.27 diopters on average. The keratometry results had a standard deviation of 2.03 diopters. The range of intraocular lens (IOL) power was determined to be between 17.52 and 28.52 D, with the standard deviation (SD) being 2.98 and the middle value (M) being 21.02. According to calculations, the intraocular lens (IOL) power ranges from 17.52 to 28.52 D. Summary of the analyzed sample’s preoperative and postoperative monocular visual and refractive data is presented in Table 1.
Median (Range) |
Preoperative |
Three months Post-operative |
p-value |
---|---|---|---|
UDVA |
0.71 (0.67) 0.48 (0.10 to 2.04) |
0.10 (0.19) 0.08 (−0.08 to 0.71) |
< 0.05 |
CDVA |
0.22 (0.25) 0.13 (0.00 to 0.84) |
0.06 (0.12) 0.00 (−0.09 to 0.39) |
< 0.05 |
Sphere (D) |
0.11 (3.48) 0.65 (−9.78 to 5.51) |
−0.51 (0.53) −0.52 (−1.51 to 0.52) |
< 0.05 |
Cylinder (D) |
−0.72 (0.72) −0.52 (−2.52 to 0.00) |
−0.55 (0.46) −0.52 (−1.52 to 0.00) |
>0.05 |
SE (D) |
−0.28 (3.68) 0.52 (−11.04 to 4.91) |
−0.78 (0.55) −0.89 (−1.64 to 0.14) |
>0.05 |
UNVA |
0.98 (0.68) 1.02 (0.12 to 2.10) |
0.16 (0.24) 0.12 (0.00 to 1.02) |
< 0.05 |
DCNVA |
— |
0.39 (0.38) 0.24 (0.00 to 1.02) |
— |
The results of the patient’s refractive and monocular vision tests taken before and three months after surgery are shown in Table 1. It was unable to evaluate whether or not the changes in manifest refraction were statistically significant (p > 0.05) due to the inconsistent nature of the baseline data. Despite this, strong evidence of a substantial improvement was seen and statistically significant for both the UDVA and the CDVA (p 0.05). Similarly, statistical analysis revealed that, compared to prior years, UNVA showed a significant growing trend (p = 0.05).
This case series examined a novel EDOF IOL that corrected spherical aberration to enhance depth of focus. The first human EDOF IOL test. The defocus curve indicates that the depth of focus rises, enabling functional close, mid, and distant vision. Three months post-surgery, the dataset exhibited mean monocular UDVA and UNVA values of 0.10 \(\pm\) 0.19 and 0.16 \(\pm\) 0.24, respectively. Despite having 4 micro-monovision patients, our results are similar to a previous study comparing EDOF IOLs [5, 8, 9]. An EDOF IOL that corrected spherical aberration had median monocular UDVA and UNVA values of 0.13 and 0.14 months after implantation, according to Giers et al. [8]. Grabner et al. [5] found that patients with monocular IC-8 IOLs (pinhole design) had mean UDVA and UNVA values of 0.06 \(\pm\) 0.08 and 0.11 \(\pm\) 0.15 one month post-implant. The researched EDOF IOL may offer intermediate and near visual performance comparable to existing models.
"EDOF IOLs enhance near vision with a little residual myopic error in the non-dominant eye or both [10, 11]. In our investigation, 4 micro-monovision patients had a mean postoperative spherical equivalent of -0.78 \(\pm\) 0.55 D utilizing this method. Monocular postoperative UNVA differs from DCNVA, like other refractive and diffractive EDOF IOLs [5, 8, 9, 10]. A mean DCNVA of 0.32 \(\pm\) 0.19 and 0.39 \(\pm\) 0.21 was seen 6 months after diffractive IOL implantation for AT LARA 829MP and Tecnis Symfony [12]. Another study [13] revealed a mean DCNVA of 0.35 \(\pm\) 0.14 in 20 individuals implanted bilaterally with the refractive EDOF IOL. This series shows that micro-monovision or bilateral residual myopic methods with the EDOF IOL improve close, intermediate, and distant vision.
The defocus curve showed mean corrected distance visual acuities of 0.14 \(\pm\) 0.14 and 0.30 \(\pm\) 0.21 at -1 and -1.5 D. This suggests the EDOF IOL studied may provide intermediate vision like regular IOLs [8, 9, 10, 11, 12]. The refractive EDOF IOL improved the depth of focus through 2.0 D defocus, performing best at 1.0 and 1.5 D [14]. Researchers observed that refractive EDOF IOLs with -1.0 and -1.5 D defocus had mean postoperative distance-corrected visual acuity values of 0.08 \(\pm\) 0.09 and 0.15 \(\pm\) 0.11, respectively [15]. Grabner et al. [5] found that the pinhole-based EDOF IOL IC-8 maintained 20/40 or better visual acuity for 12 months following surgery, ranging from +0.50 to -1.50 D. The series has an average corrected distance visual acuity of 0.30 for defocus levels +1.00 to -1.50 D. Post-operative DCNVA was 0.30 or better in 78.6% of eyes.
We must acknowledge the inquiry’s flaws. The pilot investigation of the innovative EDOF IOL’s clinical performance has a modest sample size. A larger sample is needed to test these early findings over the short and long term. Second, IOL’s influence on ocular optics is difficult to measure using visual acuity and refractive error statistics. Validated questionnaires should assess contrast sensitivity, visual complaints, and ocular high-order aberrations. Three, this study is not a comparison. Therefore, whether this EDOF IOL outperforms a mono-focal cannot be declared. Future comparative research should address this. Finally, the lack of a standard refractive goal planning approach created a diverse patient group, making UDVA and UNVA interpretation difficult.
Finally, the Synthesis with EDOF IOL placed following cataract surgery may improve distance, intermediate, and close vision. This advanced intraocular lens (IOL) may treat a tiny amount of residual myopia using micro-monovision or bilateral residual myopia to improve near visual acuity. More research is needed to discover how this EDOF IOL affects vision and its advantages over conventional presbyopia-correcting devices. Other, larger clinical investigations must confirm this early conclusion.
This research paper received no external funding.
The author declares no conflicts of interest.
Informed consent was obtained from all participates in the study as needed.