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Three-year outcomes of a novel toric intraocular lens implantation for moderate-high myopic astigmatism in phakic eyes

BMC Ophthalmology volume 24, Article number: 362 (2024) Cite this article

Abstract

Purpose

To investigate the three-year visual, refractive outcomes and adverse events of the Eyecryl toric phakic IOL (pIOL) for moderate-to-high myopic astigmatism.

Methods

This retrospective study included eligible patients who underwent refractive surgery in one or both eyes with Eyecryl toric pIOL for myopic astigmatism. The efficacy, safety, predictability, rotational stability, vector analysis, and adverse events were evaluated in patients with spherical refraction from − 4.50 to -17.00 diopters (D) and cylindrical refraction from − 0.75 to -5.50 D.

Results

Fifty-two eyes of 28 patients were included in the study. The mean efficacy and safety index were 1.12 ± 0.35 and 1.38 ± 0.42, respectively. The mean manifest refraction spherical equivalent was − 10.06 ± 2.69 D and − 0.64 ± 0.61 D preoperatively and postoperatively at 36 months, respectively. The mean manifest astigmatism was − 2.06 ± 1.16 D and − 0.44 ± 0.48 D preoperatively and 36 months postoperative, respectively. During the final examination, 70% of the eyes showed an increase in CDVA of one or more lines compared to their preoperative state. There was a cumulative endothelial cell loss of 3.1% at 36 months postoperatively. One eye developed visually significant anterior subcapsular opacity, whereas another eye experienced pIOL opacification.

Conclusion

The Eyecryl toric pIOL demonstrated satisfactory visual acuity and refractive outcomes, as assessed by efficacy, safety and stability over a three-year period.

Peer Review reports

Introduction

Phakic intraocular lenses (pIOL) are a popular option for treatment of refraction errors particularly in patients unsuitable for corneal refractive surgeries [1,2,3]. They may have some advantages over corneal refractive surgeries including lower induced corneal aberration and dry eye, higher visual quality with magnification of the image, and reversibility of the surgery [4,5,6]. Besides these advantages, there are also some disadvantages such as endothelial decompansation, cataracts, and glaucoma [7].

Until a few years ago, the Visian Toric Implantable Collamer Lens (ICL) (Staar Surgical, Monrovia, CA, USA)—which has been shown to be effective, safe, and stable in many studies—was the only toric posterior chamber pIOL option on the market [8, 9]. Eyecryl toric pIOL (Biotech Vision Care, Ahmedabad, India) is a novel toric posterior chamber IOL and is a foldable, hydrophilic acrylic, plate-haptic structure. Early results of the Eyecryl toric pIOL were comparable in terms of safety, efficacy, and predictability to toric ICL [10,11,12]. Here, we aimed to evaluate the efficacy, safety, rotational stability, predictability, vault, vector analysis and complications of Eyecryl toric pIOL over a long-term period.

Materials and methods

This study adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from the patients. The ethics committee of University of Health Sciences, Turkey approved the study (reference no:21/521). Patients who underwent Eyecryl toric pIOL implantation for the treatment of moderate-to-high myopia and astigmatism between February 2018 and February 2019 were investigated retrospectively.

Inclusion and exclusion criteria

The inclusion criteria were ≥ 20 years age, ≥ 0.75 D manifest astigmatism, preoperative refractive stability (≤ 0.50 D alteration in the last year), endothelial cell density (ECD) > 2,200 cells/mm2, and anterior chamber depth (ACD) ≥ 2.85 mm. The study also encompasses patients with low preoperative corrected visual acuity resulting from amblyopia or degenerative myopia who have benefited from the use of corrective lenses. The exclusion criteria were any history of cataract, glaucoma, uveitis or corneal pathology, previous ocular surgery, and follow-up period less than 36 months.

Examinations

All of the participants underwent particular ophthalmologic examination including uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), cycloplegic and manifest refraction, biomicroscopic evaluation of anterior eye, intraocular pressure (IOP) evaluation by Goldmann tonometer, dilated posterior segment examination, corneal tomography (Sirius, Costruzione Strumenti Oftalmici, Italy), specular microscopy (CEM 530, Nidek, Japan), anterior segment OCT for vault measurements (Visante OCT, Carl Zeiss AG, Germany), and optical biometry (AL-Scan, Nidek, Japan). Rotational stability was measured via a free application (https://www.goniotrans.com) using a dilated and retro-illuminated anterior segment photography which 2 toric axis and the central hole was clearly identifiable. Vector analysis was performed via a free application using the Alpins method [13, 14]. All patients were examined preoperatively and postoperative on day 1, week 1, as well as months 1, 3, 6, 12, 24 and 36.

Surgical technique

The power and size calculation of the pIOL was performed using the online calculator available at the company’s website (www.biotechcalculators.com). All operations were performed by single experienced surgeon (AA) with the same technique (including preoperative marking of horizontal axis) previously described [12]. All patients received topical moxifloxacin 0.5% (Vigamox, Alcon) four times a day for one week and prednisolone acetate 0.1% (Pred Forte, Allergan) four times a day for two weeks and tapered in two weeks.

Statistical analysis

Statistical analysis was conducted using SPSS for Windows version 27.0 (IBM Corp, Armonk, NY, USA). Visual acuity measurements were converted to LogMAR units for statistical purposes. Continuous variables were represented as the mean and standard deviation. The normality of the data was assessed using the Shapiro-Wilk test. Paired samples t-test and repeated measures ANOVA were conducted to compare the visual, refractive and other clinical parameters when the data had a normal distribution. In the case of data without a normal distribution, Wilcoxon signed-rank test and Friedman test were performed. Statistical significance was considered for p-values less than 0.05.

Results

Fifty-two eyes of 28 patients (18 females [64.3%] and 10 males [35.7%]) were included and 24 of 28 patients had bilateral pIOL implantation surgery. Table 1 shows the demographics and preoperative characteristics of the patients.

Table 1 Preoperative baseline characteristics
Full size table

Efficacy

The mean efficacy index (postoperative UDVA/preoperative CDVA) was 1.12 ± 0.30, 1.14 ± 0.33, and 1.12 ± 0.35 (p = 0.916) at 12, 24, and 36 months postoperatively, respectively. At 36 months postoperatively, 48% of eyes had a UDVA of 20/25 or better (preoperative 26.9% of eyes had a CDVA of 20/25 or better) (Fig. 1). Postoperative UDVA was the same or better than preoperative CDVA in 75.5% of eyes at 36 months (Fig. 1).

Fig. 1
figure 1

Visual and refractive results of the patients 36 months after surgery. A: The cumulative Snellen visual acuity. B: Difference between UDVA and CDVA. C: Changes in lines of CDVA. D: Attempted vs. achieved spherical equivalent. E: Accuracy of spherical equivalent refraction. F: Change in spherical equivalent from preoperatively to three postoperative years. G: Change in refractive astigmatism from preoperatively to three postoperative years. H: Target-induced astigmatism vs. surgically induced astigmatism scatter plot. I: Refractive astigmatism angle of error

Full size image

Safety

At 36 postoperative months, 70% of the eyes showed an increase in CDVA in at least one line compared to preoperative period (Fig. 1). One eye showed a two-line loss of CDVA. The mean safety index (postoperative CDVA/preoperative CDVA) was 1.35 ± 0.47, 1.39 ± 0.42 and 1.38 ± 0.42 (p = 0.191) at 12, 24, and 36 postoperative months, respectively.

Refractive outcomes and stability

There was statistically significant decrease in sphere, cylinder, and SE values (p < 0.001 for all) at 12, 24, and 36 months compared to preoperative values. While there was no statistically significant difference in residual cylinder and spherical equivalent values between postoperative visits, a significant increase in sphere values (p = 0.001) was found (Table 2). The SE predictability of 79% of eyes was within ± 1.00 D; 54% of eyes were within ± 0.50 D (Fig. 1).

Table 2 Postoperative visual and refractive outcomes
Full size table

Astigmatism and vector analysis

In terms of astigmatism correction, 73% of eyes were within ± 0.50 D, 92% of eyes were within ± 1.00 D cylinder correction (Fig. 1). In vector analysis, the correction index (calculated by the ratio of the surgically induced astigmatism to target induced astigmatism) was 0.91, suggesting a mild undercorrection of 9% and the index of success was 0.21 (Fig. 2). The arithmetic mean magnitude of error and angle of error were − 0.16 ± 0.33 and 3.95 ± 16.97 degrees, respectively.

Fig. 2
figure 2

Vector analysis of refractive astigmatism of the patients 36 months after surgery

Full size image

Rotational stability

The mean deviation from the target axis was 2.38 ± 1.9, 3.83 ± 3.76, 3.62 ± 4.16, and 3.90 ± 3.47 degrees (p < 0.001) at 1 day as well as 12, 24, and 36 months, respectively. The absolute change in axis orientation was 1.44 ± 4.03, 0.21 ± 1.74, and 0.29 ± 1.87 degrees between 1 day and 12 months, 12 and 24 months, and 24 and 36 months, respectively. While 98% of the lenses were within ± 5 degree of rotation at 1 day, 92.3% of the lenses were within ± 5 degree of rotation at 36 months. One patient had a rotation of 7 degrees on the first postoperative day. However, a second procedure was deemed unnecessary because the patient had a pIOL with low cylinder power (1 D).

Vault distance

The mean central vault distance was 548 ± 169, 494 ± 159, and 473 ± 182 microns at 12, 24, and 36 months (p < 0.001) postoperatively, respectively. There was a significant decrease in vault distance each year (p < 0.001 between 12 and 24 months; p = 0.007 between 24 and 36 months).

Intraocular pressure

The mean intraocular pressure was 14.6 ± 2.39 mmHg preoperatively and 13.8 ± 1.72, 15.7 ± 3.00, and 14.6 ± 3.93 mmHg at 12, 24, and 36 months (p = 0.087) postoperatively, respectively.

Endothelial cell loss

The mean endothelial cell density (ECD) decreased from 2716 ± 293 cells/mm2 preoperatively to 2682 ± 294, 2639 ± 275, and 2632 ± 290 cells/mm2 at 12, 24, and 36 months (p = 0.077) postoperatively, respectively. The cumulative endothelial cell loss was 3.1% at 36 months postoperatively.

Long-term adverse events

Visually insignificant anterior subcapsular opacities developed in two eyes (Fig. 3-A). The central anterior subcapsular opacity caused two lines of loss in CDVA in the right eye of a 31-year-old patient (Fig. 3-B). The patient was advised to have pIOL explantation and cataract surgery explaining the risks and benefits, but he did not accept the surgery as of the last visit. A pIOL opacification was seen in the left eye of a 38-year-old patient (Fig. 3-C). She noticed the mild visual loss in her left eye, but her CDVA was 20/20. She had not been offered pIOL explantation as of her last visit.

Fig. 3
figure 3

A: Visually insignificant anterior subcapsular opacities in two different eyes. B: Visually significant anterior subcapsular opacity in an eye. C: Intraocular lens opacification in an eye

Full size image

Discussion

Many studies have shown that toric ICL is safe and efficient in the management of myopic astigmatism [15,16,17]. The Eyecryl toric pIOL is relatively new to the pIOL market and showed good efficacy, safety, and predictability in previous studies [10,11,12]. This study evaluated the long term visual and refractive results of the Eyecryl toric pIOL in patients with high myopia and astigmatism. To the best of our knowledge, this study is the first to evaluate Eyecryl toric pIOL more than two years follow-up period.

In a recent prospective study, authors compared toric ICL and Eyecryl toric pIOL [10]. There were no significant differences in the mean CDVA, UDVA, SE, and residual astigmatism at the end of the second year; 72% of eyes in toric ICL group and 76% of eyes in Eyecryl toric pIOL group possessed a 20/20 or better UDVA. These percentages were much higher than our study (17%). The main reason for the difference was the mean preoperative CDVA: 0.21 ± 0.15 LogMAR in our study. The authors reported that the mean preoperative CDVA was 0.04 ± 0.10 and 0.03 ± 0.06 LogMAR in toric ICL and Eyecryl toric pIOL groups, respectively [10]. This could limit the percentage of a higher UDVA. The authors found that 52% of the eyes in toric ICL group and 64% of eyes in Eyecryl toric pIOL group showed an increase in CDVA of at least one line at the end of the second year [10]. Here, 70% of eyes showed an increase in CDVA of at least one line. Again, this difference could be related to preoperative CDVA. The authors found that 84% of eyes in the toric ICL group and 92% of eyes in the Eyecryl toric pIOL group were within ± 0.50 D of refractive astigmatism. The correction index of vector analysis was 0.94 and 0.98 in toric ICL and eyecryl toric pIOL groups, respectively. In our study 73% of eyes were within ± 0.50 D residual astigmatism and correction index was 0.91. These results were slightly less favourable than expected.

In terms of astigmatism correction, a 63.6% decrease in astigmatism was found in the FDA toric ICL study, and the mean manifest cylinder value was 0.53 D at 12 months [16]. These results were similar to our study in which the mean cylinder value was 0.44 D at the end of 36-month follow-up. Likewise, Schallhorn et al. reported a 0.58 D of manifest astigmatism at 12 months [18]. Both Kamiya et al. and and Sari et al. published 0.49 D of manifest astigmatism at 36 months [17, 19]. The astigmatism results of our study were stable and comparable to the literature.

The mean central vault height showed a significant decrease over time in the present study. In a previous study with a large cohort (964 eyes) and 36 months of follow-up period after ICL implantation, a decrease in vault height was significant after postoperative 3 months [20]. The vault height decision was made subjectively on biomicroscopic examination comparing with corneal thickness in that study. In another study of the same author with objective measurement of vault height via anterior segment OCT, a continuous reduction of central vault height was observed especially in the first 6 months [21]. Li et al. reported that the vault height significantly decreased throughout 2.5 years follow-up period after ICL implantation [22]. The extent of decrease was higher in eyes with shallower ACD and higher ICL power. A vault height decrease could be related to age-related accommodation changes and an increase in the crystalline lens thickness as previously demonstrated [23]. This situation could explain the myopic shift over the long term.

Regarding ECD loss after implantation of pIOLs, Jimenez-Alfaro et al. stated that the mean ECD loss was 6.57% after two years [24]. An FDA trial reported 8.4–9.7% ECD loss after three years [25]. Kamiya et al. reported that the mean ECD loss was 3.7% after four years [26]. Alfonso et al. stated 7.7% loss 5 years after surgery [27]. In our study, cumulative endothelial cell loss was 3.1% 3 years after surgery, which is slightly lower than previous studies [19, 24,25,26,27,28,29].

Two asymptomatic and one symptomatic (two lines loss in CDVA) anterior subcapsular opacities (5.8%) were observed here. While the vault heights of the patients with asymptomatic cataract were 370 and 220 microns, the vault height of the patient with visually significant cataract was 530 microns at 36 months. A low vault height is a major reason for cataract formation after pIOL implantation, but in our patients the vault heights were within normal range. Other factors like surgical trauma, subclinical inflammation, pIOL material, patient age, and degree of myopia could be responsible for anterior subcapsular opacities [26, 27]. In the FDA toric ICL study, five asymptomatic and one symptomatic ASO (3.6%) were observed at 12 months postoperatively [16]. Kamiya et al. reported 4 (8%) asymptomatic ASO and Sari et al. reported 2 (5.8%) asymptomatic ASO at 36 months postoperatively after toric ICL implantation [19, 30]. Brar et al. did not report any cataract formation in the toric ICL and Eyecryl pIOL groups at 24 postoperative months [10]. We found that the frequency of ASO was compatible with the literature.

Interestingly, pIOL clouding was observed in one eye (1.9%) of a patient whose vault height was 490 microns at 36 months postoperatively. Her CDVA was 20/20 and she noticed only mild visual loss. Calcification could be seen in hydrophilic acrylic IOLs [31]. This could be related to IOL manufacture, packaging, surgery, adjuvants, and the patients’ metabolic conditions [32]. The patient was advised to have close follow-up period because of her visual acuity. To the best of our knowledge, this is the first pIOL clouding report among Eyecryl phakic IOLs.

The retrospective study design and relatively small size of the cohort are the main limitations of the study. Furthermore, although it is not ideal, we had to include both eyes of the 24 patients to preserve the power of the study. Also, 36 months of follow-up could be insufficient to assess the long-term adverse events of the Eyecryl toric pIOL—especially considering the young age of the patients. Nonetheless, this is the first study to evaluate the visual and refractive outcomes of the Eyecryl toric pIOL for 36 months follow-up period.

In conclusion, Eyecryl toric pIOL delivered satisfactory results in terms of efficacy, safety, and stability. There were no significant vision-threatening adverse events during the 36 months of follow-up. These findings could support the view that Eyecryl toric pIOL performs well in moderate to high myopia and astigmatism in a three-year follow-up period.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

Thanks to Semih Cakmak for assistance with statistical analysis.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors and Affiliations

  1. University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Olimpiyat Bulvari Yolu, Basaksehir, Istanbul, 34480, Turkey

    Yusuf Berk Akbas & Yusuf Yildirim

  2. University of Health Sciences, Beyoglu Eye Training and Research Hospital, Istanbul, Turkey

    Burcin Kepez Yildiz

  3. Jupiter Eyes Augentagesklinik, Koenigs Wusterhausen, Germany

    Mehmet Emin Sucu

  4. Dunya Goz Hospital, Atakoy, Istanbul, Turkey

    Alper Agca

  5. Johns Hopkins University, The Wilmer Eye Institute, Maryland, USA

    Ugur Tunc

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  1. Yusuf Berk Akbas
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Contributions

All authors contributed to the writing and design of the manuscript. Y.B. Akbas, B.K. Yildiz, and M.E. Sucu completed this study’s data collection, data analysis, and manuscript writing. A. Agca, U. Tunc and Y. Yildirim performed the study conception, critical revision, and manuscript modification. All authors have read and agreed to the published version of the manuscript.

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Correspondence to Yusuf Berk Akbas.

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Ethics approval and consent to participate

This study adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from the patients. The ethics committee of University of Health Sciences, Turkey approved the study (reference no:21/521). Informed consent was obtained from all individual participants included in the study.

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Akbas, Y.B., Yildiz, B.K., Sucu, M.E. et al. Three-year outcomes of a novel toric intraocular lens implantation for moderate-high myopic astigmatism in phakic eyes. BMC Ophthalmol 24, 362 (2024). https://doi.org/10.1186/s12886-024-03633-0

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