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Clinical observations of EVO-ICL implantation with single incision without viscoelastic agent

BMC Ophthalmology volume 24, Article number: 344 (2024) Cite this article

Abstract

Background

To investigate the safety and effectiveness of non-viscoelastic agent technique for EVO-ICL implantation.

Methods

A total of 181 myopia eyes that underwent non-toric ICL without viscoelastic agent through single incision from Beijing Tongren Hosipital were included. An analysis was conducted on the quantity of haptics that were initially implanted intraoperatively into the posterior chamber. Intraocular pressure (IOP) was evaluated at before and 2 h,24 h,1week,6month after surgery. Anterior chamber volume(ACV), anterior chamber depth(ACD), anterior chamber angle(ACA), pupil diameter(PD) and corneal densitometry density (ECD) were evaluated at before and 24 h postoperatively. Refractive outcomes were investigated at before, 24 h ,7 days and 6months. Vault was evaluated at 24 h ,7 days and 6months.

Results

The efficacy and safety indices were 1.30 ± 0.32 and 1.31 ± 0.32, respectively. Of 181 eyes, 99 eyes received 4 haptics on the first attempt without any adjustment, and 72 eyes received lens alignment without an viscoelastic agent. The success rate of the viscoelastic agent free procedure was 94.5%. Two hours postoperatively, IOP was 17.41 ± 3.77 mmHg, which was significantly higher than baseline value (t = 8.930, P < 0.000), however there was no significant difference between preoperative IOP and IOP at 1 day ,1 week and 6 months postoperatively. The ECD changed from 2895.52 ± 253.73 cells/mm2 preoperatively to 2873.66 ± 244.17 cells/mm2 at 1 day and 2882.63 ± 239.97 postoperatively, and the difference was not statistically significant (t = 1.811, P = 0.072). The ACA was narrowed by 42% on the first day.

Conclusion

The pure viscoelastic agent free technique is an efficient and safe way for ICL implantation. It can be a safer method of ICL implantation because of it reduces the risk of complications associated with ocular hypertension at the early postoperative stages.

Trial registration

Chinese Clinical Trial Registry (ChiCTR2000036335) at August 20, 2020.

Peer Review reports

Background

Posterior chamber phakic implantable collamer lens with a central hole (ICL-V4c) have been widely used for the correction of myopia, especially high myopia due to their capacity to achieve good postoperative visual acuity and visual quality [1, 2].

With the presence of the central hole, the impact on aqueous humor circulation is reduced, and the postoperative complications [3,4,5], such as pupillary block glaucoma and anterior subcapsular opacification are decreased. Therefore, the surgical adaptation of ICL-V4c is gradually expanding to middle and low myopia and has achieved the same predictability and safety [6,7,8].

East and Southeast Asia reported high prevalence of myopia in young adults, approximately 80–90% [9]. China is a country with a high incidence of myopia, more than two hundred thousand ICL surgeries have been performed. And a bigger market is yet to be expand. At present, the surgery is usually performed in some large clinical centers with application of auto-I/A system. There is still a chance of residual viscoelastic causing ocular hypertension (OHT). OHT is one of the main postoperative complications [10, 11], mostly occurred within 1 h. Chen and Sri found that the prevalence of OHT was 31.82% [11] and even up to 60% [12] at 24 h after surgery. IOP peaks of 30 mmHg or more in the early period after surgery may be associated with corneal epithelial edema and pain [13, 14]. Recently, doctors have gradually modified the surgery and limited the use of viscoelastic agents: From viscoelastic agent injected twice in conventional ICL V4c implantation [7, 15] to once in the one-step technique [16, 17] and to not at all in pure ICL implantation [18,19,20]. However, in previous studies, although viscoelastic agents were not used, anterior chamber perfusion was required to maintain the anterior chamber, which still increased the costs and required operative time. After several clinical practices, the techniques were further simplified and the viscoelastic agent-free technique was developed for V4c ICL implantation. In this study, we described this procedure in detail and explored the effectiveness and safety of this pure viscoelastic agent free technique for ICL myopia correction. We focused mainly on its impact on UCVA, IOP, corneal endothelial cell density (ECD) and anterior chamber parameter in the early period and 6 months after surgery.

Patients and methods

In present study, 181 myopic eyes underwent non-astigmatic ICL (Model V4c; STAAR Surgical, Monrovia, California, USA) implantation without viscoelastic agent through single incision for myopia correction at Beijing Tongren Hospital were continuously collected from March 2022 to June 2022. Exclusion criteria comprised eye disorders or systemic disease, and an ECD < 2,000 cells/mm2. The protocol was registered with the Chinese Clinical Trial Registry (ChiCTR2000036335). This study was approved by the Institutional Review Board of Tongren Hospital and conducted in accordance with the tenets of the Declaration of Helsinki. Each patient was informed about the risks of surgery and signed an informed consent form.

Examination

All patients underwent complete a standard ocular examination, including slit lamp examination, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, intraocular pressure (Topcon, Inc. Japan), ECD (Topcon, Japan), axial length (Lenstar LS 900, Haag-Streit AG/Alcon Laboratories, Inc) and a dilated fundus examination (VOLK Super Field). Measurements of Anterior chamber volume(ACV), anterior chamber depth(ACD), anterior chamber angle(ACA), pupil diameter(PD) were performed by Pentacam (Pentacam HR, OCULUS, Germany), vault were measured by anterior segment optical coherence tomography (AS-OCT; Visante, Zeiss Meditec AG, Jena, Germany).

The ICL (ICL-V4c) power was chosen using a modified vertex formula according to the manufacturer’s suggestion. Lens size was calculated through the same protocol based on the white-to-white ratio, ACD and medical experience. All patients underwent multiple manifest refraction and finally selected nonastigmatic ICL.

ECDs were collected at baseline and 1 day postoperatively. IOP and UDVA were monitored at baseline and 2 h, 1 day, 7 days and 6 months postoperatively. Anterior chamber parameter were collected at baseline and 1 day postoperatively. Vault was collected at 1 day ,7 days and 6 months postoperatively.

Surgical procedure

The operation of ICL V4c implantation was conducted by an experienced surgeon (Ying Xiong). The pupils were dilated 1 h before surgery. A few drops of BSS(Balanced Salt Solution) instead of viscoelastic agent were added to the injector cartridge to keep the ICL hydrated. Only one 3-mm main incision was performed. The location of that is generally chosen at superior. Two distal haptics slowly reached the ciliary sulcus, then slowly pushing the ICL, the two proximal haptics were gently pressed and pushed under the iris. During ICL implantation, four haptics were intended to be directly implanted into the posterior chamber in one step. If one of the haptics failed to enter under the iris, a syringe-coupled injection needle or angled needle was used to adjust the lens into the ciliary sulcus (Fig. 1). Phacoemulsification machine with coaxial irrigation and aspiration (I/A) function was not used. And viscoelastic agent was not used during the whole process. IOP was maintained at approximately 30 mmHg at the end of surgery with BSS to observe whether the intraocular pressure increased or decreased 2 h after the operation. Antibiotic eye drops, steroidal eye drops, and artificial eye drops were prescribed following the surgery.

Statistical analysis

R packages, “lmerTest”, “emmeans”, and “reshape2”, were using during analysis. All repeated measurements were analyzed using linear mixture models with unstructured covariance matrix clustering on subject as a random effect and time as a fixed effect. When there was a significant difference appearing between time point, Bonferroni method was used to correct α values for multiple comparisons conducting. P value less than 0.05 was considered statistically significant.

Fig. 1
figure 1

Viscoelastic agent-free procedure for EVO-ICL implantation. a, A 3-mm superior clear corneal incision is made; b, A nontoric ICL V4c lens is implanted using an injector cartridge; c, three haptics are directly implanted into the posterior chamber however one haptic failed to enter under the iris; d, two haptics failed to enter under the iris; e, three haptics failed to enter under the iris; f, four haptics were directly implanted in the posterior chamber; g, lens is adjusted in the ciliary sulcus by a syringe-coupled injection needle; h, lens is adjusted in the ciliary sulcus by an angled needle; i, stable anterior chamber

Full size image

Results

Subjects and baseline biometrics

Upon statistical analysis of 181 eyes of 161 patients, we concluded that the success rate of using a non-viscoelastic agent in these eyes was 94.5%. Due to excessive tension, in 10 eyes of 10 patients, a minimal amount of viscoelastic agent (Amvisc; Bausch & Lomb, Shandong, China) was injected in front of the ICL to adjust it into the posterior chamber. Baseline biometrics are shown in Table 1.

Table 1 Patient and study eye characteristics
Full size table

Of 181 eyes, 99 eyes received 4 haptics, 23 eyes received 3 haptics, 40 eyes received 2 haptics, 10 eyes received 1 haptics, and 9 eyes received 0 haptics on the first attempt without adjustment. The ratio is shown in Figure 2.

Fig. 2
figure 2

Proportion of initial ICL insertion into posterior chamber

Full size image

According to the depth of the anterior chamber and the habits of the surgeon, a syringe-coupled injection needle was used in 69 eyes, and an angled needle was used in 3 eyes to adjust the lens in the ciliary sulcus. No adverse complications occurred during the operation.

Efficacy and safety

There were no intra-, peri- or postoperative complications in follow-up period. The mean efficacy index (postoperative UDVA/preoperative CDVA) was 1.30 ± 0.32. The safety index (postoperative CDVA/preoperative CDVA) was 1.31 ± 0.32. No eyes lost one or more lines of CDVA (Fig. 3). Loss of one line of CDVA was observed in seven eyes (4%). These 7 eyes were all the second operation eyes, and 2 weeks postoperative followed up were required, and the visual acuity returned to the preoperative CDVA. After 6 months of follow-up, no postoperative complications such as cataract were occurred.

Fig. 3
figure 3

(A) UDVA vs CDVA—comparison of uncorrected to preoperative corrected distance visual acuity. (B) Safety (Change line in CDVA)

Full size image

Intraocular pressure

Two hours postoperatively, the intraocular pressure was 17.41 ± 3.77 mmHg, which was significantly higher than the preoperative value (t = 8.930, P < 0.000), while there was no significant difference between the preoperative IOP and 1 day and 1 week postoperatively (Fig. 4). The IOP was higher than 25 mmHg in 4 eyes at 2 h after the operation, 28 mmHg, 28 mmHg, 32 mmHg, and 41 mmHg. A viscoelastic agent was used in the last two eyes. Once the IOP was more than 30mmgh, 2% pilocrutin eye drops (1–2 drops) were used. After 30 min of observation, the IOP decreased and gradually returned to normal. None of the patients underwent anterior chamber drainage. The IOP remained stable for 1 h without an increasing trend.

Fig. 4
figure 4

Intraocular pressure (IOP) at each follow-up time point. Error bars represent standard deviation, *P < 0.05

Full size image

Endothelial cell density

The ECD changed from 2895.52 ± 253.73 cells/mm2 preoperatively to 2873.66 ± 244.17 cells/mm2 at 1 day postoperatively (t = 1.811, P = 0.072). And the ECD of 77 eyes of 58 patients who completed 6months follow-up were 2882.63 ± 239.97 cells/mm2.The difference was not statistically significant. In addition, there was no significant difference between baseline, 1 day and 6months postoperatively in the coefficient of variation (CV) or hexagonal cell ratio (6 A), and the CV changed from 41.39 ± 5.80 preoperatively to 40.92 ± 4.93 1 day postoperatively (P > 0.05). The 6 A changed from 42.06 ± 6.86 preoperatively to 40.97 ± 7.71 1 day postoperatively (P > 0.05).

Anterior chamber parameter and Vault

Table 2 Comparison of preoperative and postoperative differences of different ophthalmic parameters
Full size table

Preoperative and postoperative (1 day) data of anterior chamber parameters were summarized in Table 2. The CV, ACD, and ACA were significantly lower postoperatively than before surgery, and remained stable for 6 months after surgery. The PD 1 day postoperatively was basically the same as that before the operation (p = 0.80).

The average vault 1 day postoperatively was 0.614 ± 0.21 mm, which decreased to 0.539 ± 0.18 mm at 1 week. And maintained 0.534 ± 0.19 mm at 6 months. The difference was statistically significant (t = 9.510, p = 0.000). Seven eyes had vault less than 0.200 mm on the first day after surgery, and their CV, ACD and ACA was 103.00 ± 29.17 mm3, 2.77 ± 0.28 mm, 23.56 ± 6.11°, compared with other normal vault (250–1000 μm) eyes, the difference of CV and ACA was not statistically significant (t=-0.574, p = 0.567; t = 173, p = 0.414), while that of the ACD was significant lower (t=-2.430, p = 0.016). The vault of these 7 eyes at 1 day was 0.152 ± 0.31 mm and significantly increased to 0.210 ± 0.40 mm at 1 week. (t = 5.148, p = 0.004).

Discussion

Through the continuous development and improvement of ICL implantation technology, implantation of an EVO-ICL with a central hole has become the most mainstream surgical method, not only for high myopia but also for low and moderate myopia. Patients with moderate to low myopia require higher postoperative visual quality than those with high myopia. This forces the surgeons to continuously simplify the operation plan, reduce the anterior chamber operation, avoid the occurrence of OHT, improve postoperative vision and patient satisfaction. At present, there are more than 1,000 hospitals in China to carry out refractive surgery, there are thousands of laser corneal refractive surgery doctors, while only a few hundred are ICL doctors. We hope that this article will help more doctors simplify surgical protocols, reduce OHT and improve patient satisfaction by elaborating this single incision without viscoelastic agent methods.

During traditional ICL implantation procedures, an ophthalmic viscoelastic agent was intended to protect endothelial cells and stabilize the anterior chamber [21]. However, with advances in technology and the simplification of surgical procedures, elevated IOP caused by viscoelastic agent retention has gradually become a major concern. High IOP may be associated with pain, corneal epithelial edema, optic disc damage and slow vision recovery [10, 22]. IOP peaks up to 35 mm Hg and can cause corneal endothelial cell damage and loss [23]. Pan [19] introduced ICL implantation with continuous infusion and a single-handed anterior chamber maintainer (ACM). Qin [18] developed a hands-free ACM. With continuous infusion, ICL implantation can be performed without the use of viscoelastic agent.While the anterior chamber space is limited, the procedure and operation time were increased.

Therefore, in the current study, we introduced a modified technique, single incision without viscoelastic agent and ACM, for use in ICL implantation and investigated its safety and effectiveness for clinical application by observing IOP, ECD and anterior chamber parameter after surgery.

No vision-threatening complications were observed, and no CDVA was lost. The efficacy and safety indices were 1.30 and 1.31, respectively. These outcomes are comparable to those reported in previous studies [16, 24]. The ACA was narrowed by 42% on the first day in this study, which was similar to that in previous studies[25], [26], and by 39–45% at 1 month. The mean vault was stabilized at 539 μm, which was within the acceptable range. All corneal endothelial cell parameters, including ECD, CV, and 6 A were stable, without significant differences from the preoperative values. 6 A is an important indicator of corneal endothelial cell function which showed that this viscoelastic agent -free method was not associated with additional damage to corneal endothelial cells.

Almalki [27] found that out of 534 patients, 58 patients experienced IOP elevation after ICL implantation. Senthil [22] found that 27% of cases experiencing high IOP were caused by viscoelastic agent residues. In this study, only four eyes had an IOP higher than 25 mmHg, and two had an IOP higher than 30 mmHg. A viscoelastic agent was applied to these two eyes. This suggests that the use of viscoelastic agent still is affected the recovery of IOP, and the viscoelastic agent free method is effective in controlling the postoperative IOP increase and promoting IOP recovery after surgery. The key point of this viscoelastic agent free technique is based on a good self-close corneal incision making, appropriate pupil size, smooth ICL implantation and gentle adjustment of the haptics into the posterior chamber.

Of 181 eyes, 54.7% eyes successfully received 4 haptics at one time, and 42.1% eyes underwent an adjustment of the ICL’s position using a syringe-coupled injection needle or an angled needle. There was no injection of viscoelastic agent, which greatly reduced the operation time and reduce the use of IA consumables.

However, the limitations of this study should be mentioned. First, the patients included in this study were all non-astigmatic ICL, which required no precise position adjustment. Second, the data in this study were obtained from very experienced surgeons. This surgery requires a certain learning curve. For beginners, it is still necessary to use viscoelastic agent to ensure anterior chamber stability and surgical safety. Third, the observation time was short, we will further observe the effect of this surgical protocol on the corneal endothelium and lens.

Conclusions

In conclusion, the results of this study indicated that ICL implantation without viscoelastic agent via single incision technique is safe and effective and could avoid viscoelastic agent related IOP elevation. It is worthy of clinical promotion for its shortening the operation time and reducing the operating costs.

Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

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Funding

This work was supported by research and transformation application of capital clinical diagnosis and treatment technology by Beijing Municipal Commission of Science and Technology [number Z201100005520043; http://sq.bjkw.net.cn/; Fengju Zhang]; and the priming scientific research foundation for the junior researcher in Beijing Tongren Hospital, Capital Medical University (2019-YJJ-ZZL-042, http://www.trkygls.com/business/login.jsp; Yu Li).

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  1. Beijing Tongren Hospital, Beijing Tongren Eye Center, Capital Medical University, Beijing, 100730, China

    Yu Li, Fengju Zhang & Ying Xiong

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Contributions

The design of the study, conducting the study, review and approval of the manuscript: Ying Xiong Data collection, data management, data analysis, interpretation of the data, preparation of of the manuscript and figures : Yu Li Made contribution the design of work: Fengju Zhang All authors read and approved the final manuscript.

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Correspondence to Ying Xiong.

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This research followed the tenets of the Declaration of Helsinki. And approved by the Institutional Ethics Committee of Beijing Tongren Hospital (ChiCTR2000036335), Capital Medical University. All participants provided signed informed consent for their participation.

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Li, Y., Zhang, F. & Xiong, Y. Clinical observations of EVO-ICL implantation with single incision without viscoelastic agent. BMC Ophthalmol 24, 344 (2024). https://doi.org/10.1186/s12886-024-03587-3

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BMC Ophthalmology

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