Implantable Collamer Posterior Chamber Intraocular Lenses: Effectiveness, Safety and Perioperative problems in a sample of Lebanese population

doi:10.21203/rs.3.rs-4155375/v1

Download PDF

Research Article

Implantable Collamer Posterior Chamber Intraocular Lenses: Effectiveness, Safety and Perioperative problems in a sample of Lebanese population

https://doi.org/10.21203/rs.3.rs-4155375/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Background:

The Implantable Collamer Lens (ICL) has gained recognition in refractive surgery for its stability and ability to achieve reversible refractive outcomes.

Aim:

Our study seeks to assess the safety and efficacy of the ICL with a central hole for vision correction procedures within the Lebanese population. Through this investigation, we aim to enhance our understanding of ICLs and their applicability in refractive surgeries, thus contributing valuable insights to the existing body of knowledge in this field.

Methods:

We conducted a prospective cohort study spanning two years. The study included 116 eyes of 58 patients who underwent surgical implantation of the Visian ICL V4c model. The participants were patients aged between 20 and 45 years, with a stable history of refraction and a medical history of myopia ranging from −2.00 to −20.0 diopters (D) and cylinder up to 3 D. Refractive outcomes, intraocular pressure, and corneal endothelial cell were evaluated one year and two years post operatively.

Results:

During the two years of follow-up, we observed a significant decrease in the UDVA (uncorrected distance visual acuity), CDVA (corrected distance visual acuity), SPH (sphere), CYL (cylinder), and SPH EQ (sphere equivalent). However, there was no variation in the IOP (intraocular pressure) recorded, and the ECC (endothelial cell count) remained stable during the first year following the surgery, but decreased slightly during the second year. Furthermore, we found that an increase in the anterior chamber depth value is associated with a decrease in ECC loss. Importantly, no complications were noted during the two years of postoperative follow-up.

Conclusion:

The implantation of the ICL is a safe and effective treatment for myopic astigmatism, improving visual acuity without complications.

Implantable Collamer Lens (ICL)

EVO-ICL

Visian ICL

Toric ICL

safety

efficacy

stability

myopia

astigmatism

complications

refractive surgery.

Keratorefractive surgery has evolved significantly over the past few decades providing an improvement in both visual acuity and quality of life for individuals seeking vision correction. Among the various methods, the posterior chamber phakic intraocular lens has emerged as a game-changer in treating astigmatism, myopia, and hyperopia.

The Implantable Collamer Lens, was initially rigid and made of materials such as PMMA. Limitations of the early ICL models included the surgical techniques, comfort, and potential complications¹. The newer models like the Visian ICL (V4 and V5 models), Toric ICL, and the advanced EVO Visian ICL are foldable and made of Collamer. This last material offers exceptional biocompatibility, flexibility, and optical clarity².

The implantation of ICL offers multiple benefits. These benefits include the stability and reversibility of refractive error correction. In comparison to other keratorefractive surgeries such as PRK and LASIK, ICL surgery doesn’t alter or reshape the corneal tissue. This facilitates faster post-operative healing and improvement of visual acuity with minimal discomfort.³ For example, individuals presenting with thin corneas may exhibit insufficient tissue for safe reshaping during excimer laser refractive surgery. ICL implantation is an effective treatment option for people with refractive errors and corneal disorders⁴ who aren’t eligible for laser keratorefractive surgeries. For individuals who have corneal irregularities due to keratoconus or scarring, predicting the outcomes of LASIK or PRK surgeries can be a challenging task.

However it is important to recognize the potential challenges that can come with ICL implantation. During the procedure, patients could experience bleeding, inflammation or infections, and there’s a chance of lens misalignment affecting postoperative refractive outcomes. After surgery, patients might notice issues like glares, halos, or dry eyes. Thought not common, there’s also a possibility of developing cataracts, retinal detachment, or increased pressure in the eyes ⁵. That’s why it is crucial for patients to understand both the benefits and the risks of this surgery, and for healthcare providers to monitor them to ensure everything goes smoothly.

Examining ICL procedures in Lebanon offers a chance to improve eye care and surgical results. With a high prevalence of myopia⁶ and growing interest in advanced treatments, studying ICL implantation could greatly benefit patients. However, despite its popularity, there is a shortage of research in this field. Therefore, more studies are needed to inform healthcare decisions and enhance the quality of visual acuity.

2.1. Study population:

We conducted a prospective cohort study spanning the years of 2021 to 2023, at the Eye and Ear Hospital in Lebanon. Our research methodology sought to provide an in-depth exploration into the outcomes following ICL implantation among a carefully defined cohort addressing the cases of moderate to high myopia and myopic astigmatism.

In this study, our participant pool was made of 58 patients, in other words 116 eyes. The age range of the selected patients was 20 to 45 years old. Our research included participants with a consistent and stable refraction history over the preceding year, unsatisfactory correction with contact lenses or glasses in addition to a past medical history of myopia ranging from − 2.00 to − 20.0 diopters (D) with astigmatism of 3 D or less. The inclusion criteria were subsequently adjusted to take into account a corneal diameter larger than 11 mm and an interior anterior chamber depth (ACD) of more than 2.9 mm, measured precisely from the endothelium. Furthermore, our inclusivity extended to individuals for whom extreme dry eye, keratoconus, high refractive errors, or a thin residual stromal bed rendered standard corneal-based laser operations impractical.

Exclusion criteria were equally comprehensive, excluding individuals with an ACD below 3.00 mm and an anterior chamber angle less than grade 2 as determined by gonioscopic examination. Plus, individuals with a history of ocular surgeries, glaucoma, uveitis as well as corneal and retinal disorders were excluded from the study.

2.2. Preoperative evaluation:

To determine a patient's visual characteristics before surgery, a thorough preoperative evaluation is necessary. The preoperative assessment includes various measurement of the patient's ocular characteristics.

First, the refractive error was determined by measuring the monocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), the sphere (SPH), the cylinder (CYL), and the spherical equivalent (SPH EQ) of each eye of the patients. Secondly, the white to white diameter (WTW) was recorded. Thirdly, the corneal thickness was determined via the Oculus Pentcam AXL Wave and the internal anterior chamber depth (ACD) was evaluated via the Zeiss IOLMaster 700. The intraocular pressure (IOP) was retained using an applanation tonometer and the endothelial cell count (ECC) was measured using the Specular Microscope NIDEK CEM-530.

In addition to that, a slit lamp examination was performed to eliminate any possible ocular pathology, and a funduscopic examination was done to rule out any possible fundus pathology.

2.3. Selection and sizing of the ICL:

The ICL comes in multiple types. The Visian ICL is available in V4 and V5 models and is designed to correct myopia and hyperopia, providing a solution for patients with spherical refractive errors. On the other hand, the Toric ICL extends its capabilities to correct astigmatism in addition to spherical errors. The EVO Visian ICL is technologically advanced, featuring improvements in optical performances and centration while addressing myopia and hyperopia like the standard Visian ICL. The Visian ICL and the Toric ICL are the most recent ICL models. These lenses are designed with a central port to avoid iridotomy or iridectomy that was required in the initial models of ICL. In our case, we implanted Visian V4c ICL model. The preoperative measurements such as WTW diameter and the ACD play a pivotal role in order to determine the appropriate size of the ICL, ensuring that it aligns seamlessly with the eye’s anatomical structures.

2.4. Surgical procedure:

To implant the ICL, a series of intricate and sophisticated steps must be taken. Commencing with pupillary dilation and the administration of a local anesthetic, a small incision (typically around 2.8 to 3.2 mm in size) is made at the temporal corneal margin. This incision facilitates the introduction of a sodium hyaluronate-based viscoelastic substance aimed at retaining the anterior chamber’s structure. The collapsible nature of the ICL allows it to be positioned in the posterior chamber behind the iris and many cases in the ciliary sulcus while avoiding contact with the crystalline lens. Subsequently, precise alignment and centration of the lens with the visual axis must be ensured, followed then by pupillary constriction.

2.5. Postoperative follow up:

Postoperative surveillance following Implantable Collamer Lens implantation bridges the surgical intervention to the patient's sustained visual well-being. The initial postoperative assessment, conducted within the inaugural 24 to 48 hours, helps detect any early complications. Sequential follow-up appointments were made over a period of 1 year and then 2 years post operation constituting a comprehensive evaluation of the procedure's enduring efficacy and safety. Within this structured framework, meticulous examinations were made especially assessing the refractive outcomes and visual acuity (post op UDVA and CDVA as well as the SPH, the CYL, and the SPH EQ), endothelial cell density, IOP, and anterior segment measurements.

2.6. Statistical analysis:

Data were analyzed on Statistical Package for the Social Sciences (SPSS) (IBM Corp., Armonk, NY), version 25. Continuous variables were considered normally distributed since the skewness and kurtosis values varied between ± 1.96. A repeated-measures ANOVA was performed among the total sample at baseline, aiming to compare the probability of symptoms change between baseline, T1 (= 1 year) and T2 (= 2 years). Partial Eta Squared · η2 = 0.01 indicates a small effect · η2 = 0.06 indicates a medium effect · η2 = 0.14 indicates a large effect. Statistical significance was set at p < 0.05.

3.1. Sociodemographic and characteristics of the participants

A total of 116 eyes was included in the analysis. The mean age of the patients was 26.12 ± 4.55 years, with 53.4% females. Further details about the sample are summarized in Table 1.

Table 1

Sociodemographic and other characteristics of UHR patients (n = 116).
Gender
Female	54 (46.6%)
Male	62 (53.4%)
ICL type
Non toric	48 (41.4%)
Toric	68 (58.6%)
Age (years)	26.12 ± 4.55
ACD	3.23 ± .20
CT	548.56 ± 26.80
WTW	11.45 ± .38

3.2. Repeated measures ANOVA at 1 and 2 years of follow-up respectively:

Concerning the comparison of UDVA scores, Mauchly’s test indicated that the assumption of sphericity has not been met, χ2 (2) = 299.689, p < .001. Therefore degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = .517). A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = 12.71, p < .001, η2 = .102. Post-hoc pairwise comparisons showed a statistical significance of the scores when taken two by two (baseline vs 1 year 1.072 vs .074, p < .001; baseline vs 2 years 1.072 vs 0.086, p < .001, 1 year vs 2 years .074 vs .086, p = .043).

Concerning the comparison of CDVA scores, no significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = 1.82, p = .165, η2 = .016. Post-hoc pairwise comparisons showed a statistical significance of the scores when taken two by two (baseline vs 1 year .009 vs .008, p = .957; baseline vs 2 years .009 vs .008, p = .957, 1 year vs 2 years .008 vs .008, p = 1).

Concerning the comparison of SPH scores, Mauchly’s test indicated that the assumption of sphericity has not been met, χ2 (2) = 534.595, p < .001. Therefore degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = .502). A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = 9.81, p < .001, η2 = .081. Post-hoc pairwise comparisons showed a statistical significance of the scores when taken two by two (baseline vs 1 year − 10.192 vs − .050, p < .001; baseline vs 2 years − 10.192 vs − .050, p < .001, 1 year vs 2 years − .050 vs − .071, p = .810).

Concerning the comparison of CYL scores, Mauchly’s test indicated that the assumption of sphericity has not been met, χ2 (2) = 148.201, p < .001. Therefore degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = .576). A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = .572, p = .565, η2 = .005. Post-hoc pairwise comparisons showed a statistical significance of the scores when taken two by two (baseline vs 1 year .881 vs .183, p < .001; baseline vs 2 years .881 vs .224, p < .001, 1 year vs 2 years .183 vs .224, p = .044).

Concerning the comparison of SPH EQ scores, Mauchly’s test indicated that the assumption of sphericity has not been met, χ2 (2) = 520.072, p < .001. Therefore degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = .502). A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = .572, p = .565, η2 = .005. Post-hoc pairwise comparisons showed a statistical significance of the scores when taken two by two (baseline vs 1 year 9.755 vs .041, p < .001; baseline vs 2 years 9.755 vs .041, p < .001, 1 year vs 2 years .041 vs .041, p = 1).

Concerning the comparison of IOP scores, Mauchly’s test indicated that the assumption of sphericity has been met, χ2 (2) = .979, p = .305. A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = .572, p = .565, η2 = .005. Post-hoc pairwise comparisons showed no statistical significance of the scores when taken two by two (baseline vs 1 year 12.353 vs 12.353, p = 1; baseline vs 2 years 12.353 vs 12.284, p = 1, 1 year vs 2 years 12.353 vs 12.284, p = 1).

Concerning the comparison of ECC scores, Mauchly’s test indicated that the assumption of sphericity has not been met, χ2 (2) = 929.29, p < .001. Therefore degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = .500). A significant difference was found between the scores at baseline, 1 year and 2 years respectively, F(2, 224) = .572, p = .565, η2 = .005. Post-hoc pairwise comparisons showed no statistical significance of the scores when taken two by two (baseline vs 1 year 2781.379 vs 2936.293, p = 1; baseline vs 2 years 2781.379 vs 2720.543, p < .001, 1 year vs 2 years 2936.293 vs 2720.543, p = .866).

It is of note that females had higher UDVA at 1 year (Beta = .048; p = .033), and higher CDVA at 1 year (Beta = .040; p = .049) and 2 years (Beta = .040; p = .049) compared to males respectively (Table 2).

Table 2

Repeated measures ANOVA of factors associated with the dependent variables at 1 and 2 years respectively.
Variable	Beta	p	95% Cl		Partial Eta Squared
Model 1a: UDVA at 1 year as the dependent variable
Age	.001	.695	− .004	.006	.001
Gender (males vs females*)	.048	.033	.004	.092	.040
ICL type (toric vs non toric*)	.019	.383	− .025	.063	.007
Model 1b: UDVA at 2 years as the dependent variable
Age	− .001	.767	− .005	.004	.001
Gender (males vs females*)	.033	.135	− .010	.077	.020
ICL type (toric vs non toric*)	.025	.247	− .018	.069	.012
Model 2a: CDVA at 1 year as the dependent variable
Age	− .001	.783	− .005	.004	.001
Gender (males vs females*)	.040	.049	.001	.081	.034
ICL type (toric vs non toric*)	.022	.282	− .018	.062	.010
Model 2b: CDVA at 2 years as the dependent variable
Age	− .001	.783	− .005	.004	.001
Gender (males vs females*)	.040	.049	.001	.081	.034
ICL type (toric vs non toric*)	.022	.282	− .018	.062	.010
Model 3a: SPH at 1 year as the dependent variable
Age	− .004	.552	− .018	.010	.003
Gender (males vs females*)	− .042	.513	− .169	.085	.004
ICL type (toric vs non toric*)	− .012	.850	− .139	.114	< .001
Model 3b: SPH at 2 years as the dependent variable
Age	− .001	.870	− .017	.014	< .001
Gender (males vs females*)	− .046	.524	− .190	.097	.004
ICL type (toric vs non toric*)	.011	.879	− .132	.154	< .001
Model 4a: CYL at 1 year as the dependent variable
Age	.002	.802	− .011	.014	.001
Gender (males vs females*)	.069	.226	− .043	.181	.013
ICL type (toric vs non toric*)	.043	.447	− .069	.155	.005
Model 4b: CYL at 2 years as the dependent variable
Age	.002	.698	− .010	.014	.001
Gender (males vs females*)	.031	.573	− .079	.142	.003
ICL type (toric vs non toric*)	.068	.218	− .041	.178	.014
Model 5a: SPH EQ at 1 year as the dependent variable
Age	− .003	.639	− .018	.011	.002
Gender (males vs females*)	− .006	.933	− .139	.127	< .001
ICL type (toric vs non toric*)	.008	.904	− .124	.140	< .001
Model 5b: SPH EQ at 2 years as the dependent variable
Age	< .001	.988	− .016	.015	< .001
Gender (males vs females*)	− .031	.675	− .175	.114	.002
ICL type (toric vs non toric*)	.045	.533	− .098	.189	.003
Model 6a: IOP at 1 year as the dependent variable
Age	.044	.368	− .052	.140	.007
Gender (males vs females*)	− .134	.767	-1.029	.761	.001
ICL type (toric vs non toric*)	.125	.782	− .765	1.015	.001
Model 6b: IOP at 2 years as the dependent variable
Age	.035	.443	− .055	.125	.005
Gender (males vs females*)	− .005	.990	− .845	.834	< .001
ICL type (toric vs non toric*)	− .208	.622	-1.043	.626	.002
Model 7a: ECC at 1 year as the dependent variable
Age	-21.359	.640	-111.628	68.909	.002
Gender (males vs females*)	451.269	.290	-389.115	1291.653	.010
ICL type (toric vs non toric*)	470.678	.267	-365.085	1306.441	.011
Model 7b: ECC at 2 years as the dependent variable
Age	2.454	.661	-8.608	13.517	.002
Gender (males vs females*)	16.588	.750	-86.404	119.580	.001
ICL type (toric vs non toric*)	16.72	.747	-85.706	119.146	.001

Numbers in bold indicate significant p values.

3.3. Correlations of ACD:

Higher ACD scores were significantly associated with ECC scores post op at 1 year (r = .20; p = .029) but not ECC at baseline (r = − .114; p = .224) and post op at 2 years (r = − .084; p = .372), CT (r = .041; p = .664) and WTW (r = − .069; p = .466).

3.4. Mean Values of ECC:

Preoperatively, 1 year postoperatively, and 2 years postoperatively, the mean values of ECC were 2781.38 cells, 2936.29 cells, and 2720.54 cells.

3.5. Complications:

There were no intraoperative complications documented during the ICL implantation like damage to the lens or rupture of the suspensory ligament. Additionally, no significant increase in the IOP, and no lens opacification, cataract, retinal detachment and endophtalmitis was seen during postoperative check-ups through the 2 years follow-up.

Implanting ICLs has demonstrated effectiveness in correcting myopia across a range of severity, from mild to severe across a broad spectrum of spherical equivalents (SE). The US FDA found that 59.3% of eyes had 20/20 or better visual acuity and 94.7% had 20/40 or better uncorrected visual acuity at 3 years of follow-up¹¹. Interestingly, studies have indicated that Toric ICLs are just as effective as non-Toric lenses in correcting refractive errors ¹². Our study revealed equivalent visual acuity outcomes between the Toric and non-Toric lenses. There was a no significant changes in SPH scores between the 1st and 2nd year post-operatively whether it was a Toric or non Toric ICL. However, there was only a slight increase in CYL scores, no greater than 0.75D. In a review of the literature of a total of 67 publications done by Packer M.¹³, the efficacy index, determined by dividing postoperative UDVA by preoperative CDVA, ranged from 0.90 to 1.35, with a weighted mean of 1.04. Moreover, postoperative UDVA closely matched preoperative CDVA in the majority of the 116 eyes analyzed. Therefore, the possibility of ICL implantation holds promise for significant enhancements in UDVA and notable improvements in quality of life.

Ensuring optimal outcomes and safety during ICL implantation is a top priority. One way to achieve this is by performing preoperative assessments including measurements of the ACD, the corneal thickness, the IOP, the ECC, and the proper sizing of the ICL. Additionally, the most important safety indicators postoperatively recorded were the index of safety, the IOP, the corneal endothelial cell loss, and the lens opacity ¹². The safety index can be highlighted through the consistency of the CDVA scores. Our findings showed no important variation between the scores at baseline, 1 year and 2 years of CDVA scores.

Furthermore, our results demonstrated that there was no significant rise in the IOP during the 2 years following the ICL implantation. The V4c ICL model used in our research incorporates a central port in the lens design allowing the flow of aqueous humor. The consistent intraocular pressure indicates that having a central hole in the ICL may help regulate IOP without the necessity of peripheral iridotomy¹². Possible causes of increased intraocular pressure post-surgery include retained viscoelastic substance or excessive filling of the anterior chamber during surgery, pupillary block, and malignant glaucoma. Transient IOP elevation a few hours post-procedure is associated with retained ophthalmic viscosurgical devices (OVD) ¹². To prevent an increase in intraocular pressure caused by retained viscoelastic agent, it is important to thoroughly irrigate both the anterior and posterior chambers. By omitting the initial injection of the agent, the residual amount is significantly diminished, thereby lowering the risk of retaining the viscoelastic agent and subsequently preventing pupillary block and intraocular hypertension¹⁴.

Endothelial cell counts should be closely monitored, especially in patients undergoing anterior segment surgery such as lens surgeries¹⁵. As mentioned in the results, the mean values of ECC preoperatively, 1 year postoperatively, and 2 years postoperatively, were 2781.38 cells, 2936.29 cells, and 2720.54 cells. We determined the loss of endothelial cell by assessing the percentage decrease in cell density at the center of the cornea: endothelial cell loss = (preoperative cell count − postoperative cell count)/ (preoperative cell count × 100%) ¹⁶. There was no loss of endothelial cells observed within the initial year postoperatively; however, in the second year after the surgery, the loss of endothelial cells was at 2.18%. The Yang W, Zhao J, Sun L, et al.¹⁵ noted an endothelial cell loss of 4.03%±2.2% compared to preoperative values of ECC after four years of follow-up. Data collected over 5–7 years following ICL implantation indicates an annual endothelial cell loss rate of around 1.8%. These percentages representing endothelial cell loss should be considered in the context of the typical decline in endothelial cell density related to age, which is estimated to be 0.6% per year ¹⁷.

It is important to acknowledge that our study has revealed a statistically significant negative correlation between the value of anterior chamber depth (ACD) and endothelial cell count (ECC) loss. Specifically, the findings indicate that an increase in ACD value is associated with a decrease in ECC loss. During surgical procedures that involve manipulation of the anterior chamber such as intraocular lens implantation, the corneal endothelium may experience mechanical trauma, which can result in a loss of endothelial cells. The depth of the anterior chamber may also play a role in determining the degree of trauma experienced by these cells during surgery.¹⁸

Complications after Implantable Collamer Lens (ICL) implantation are uncommon but possible. Some of these complications include an increase in intraocular pressure, endothelial cell loss, and cataract formation. In a study conducted over 10 years, 62 eyes underwent ICL implantation and 29% of patients developed cataracts. The most common type of cataract described was the anterior subcapsular opacity¹⁹.Observations done also revealed that ICL without a hole caused anterior subcapsular opacities in all eyes, while the ICL featuring a central aperture within the optic did not show any subcapsular opacities ²⁰. Therefore, having a central aperture in the ICL reduces the likelihood of potential cataract development. The newer V4c Toric ICL model was found to have decreased postoperative lens opacification²¹. None of the patients in our case developed lens opacity, and none of the patients were found to have developed cataracts, specifically anterior subcapsular cataracts. The risk factors favoring the development of cataract with ICL use are low arch height and contact between the crystalline and ICL. Other factors include abnormal aqueous humor circulation, age over 40–45, preoperative diopter greater than − 12D to -14D, and preexisting lens opacity²².

Another complication following intraocular surgeries is retinal detachment. Intraocular refractive surgeries witnessed a significant evolution with the development of the two techniques: Implantable Collamer Lens (ICL) and Clear Lens Extraction (CLE). CLE involves surgically removing the natural lens of the eye and replacing it with an intraocular lens (IOL). It's worth noting that ICL surgery does not increase the risk of retinal detachment, unlike CLE and cataract removal²³. The incidence of retinal detachment in myopic eyes of patients following ICL implantation is 2%²², while patients who have undergone CLE, it is 7.3%²⁴. This can be explained by the fact that removing the natural lens of the eye can lead to changes in the vitreous dynamics of the eye, which may result in increased traction of the retina. In our study, none of the participants developed retinal detachment following the implantation of the ICL V4c.

Firstly, generalizing our findings to larger populations can be limited by the small sample of participants selected in the analysis. Nevertheless, it is crucial to emphasize that there was no loss of follow-up. In fact, all the patients that were at the beginning of the study presented to all the appointments required. Secondly, we followed up with the participants for a short period of time only. Hence, long-term conclusions concerning the outcomes of ICL implantation can become more challenging. Furthermore, there were no comparative groups, such as individuals undergoing other types of refractive surgery, in order to compare the results we obtained. This leads to an increase in the difficulty of making comparisons and drawing solid conclusions. Just like any study, external factors such as lifestyle and socioeconomic factors, which may have influenced the patient outcomes, were not fully accounted for, introducing potential confounders.

In conclusion, our two-year prospective investigation affirms that the implantation of ICL emerges as a secure and efficient treatment avenue for managing long-term myopic astigmatism. After undergoing surgery, patients can rapidly achieve a high and stable level of visual acuity. Furthermore, no complications were noted throughout the two-year monitoring. By employing vision correction techniques, individuals can minimize their reliance on glasses or contacts, experience newfound visual autonomy, and enhance their daily productivity and self-assuredness.

Ethics Approval and Consent to Participate

The ethical committee of the Eye and Ear Hospital gave the approval necessary to conduct this study. All participants were provided full information on the study, and provided their written informed consent to participate. The study was performed following the standards for medical research involving human subjects recommended by the Declaration of Helsinki for human research.

Consent for publication:

Not applicable.

Competing interests:

The authors have nothing to disclose.

Funding:

None.

Author Contribution

AS designed the study; MG processed the data; MG drafted the manuscript; SH carried out the analysis and interpreted the results; and MR, AS reviewed the paper for intellectual content; all authors reviewed the final manuscript and gave their consent.

Acknowledgements:

The authors would like to thank all participants.

Availability of data and materials:

The datasets generated and/or analyzed during the current study are not publicly available due to restrictions from the ethics committee but are available from the corresponding author on reasonable request.

Musgrave CSA, Fang F. Contact Lens Materials: A Materials Science Perspective. Mater (Basel). 2019;12(2):261. 10.3390/ma12020261. Published 2019 Jan 14.
Pérez-Vives C, Domínguez-Vicent A, Ferrer-Blasco T, Madrid-Costa D, Montés-Micó R. Optical quality of hyperopic and myopic phakic intraocular lenses. Indian J Ophthalmol. 2014;62(4):437–41. 10.4103/0301-4738.119423.
Dick HB, Alió J, Bianchetti M, et al. Toric phakic intraocular lens: European multicenter study. Ophthalmology. 2003;110(1):150–62. 10.1016/s0161-6420(02)01447-1.
Emerah SH, Sabry MM, Saad HA, Ghobashy WA. Visual and refractive outcomes of posterior chamber phakic IOL in stable keratoconus. Int J Ophthalmol. 2019;12(5):840–3. 10.18240/ijo.2019.05.22. Published 2019 May 18.
Zhang H, Gong R, Zhang X, Deng Y. Analysis of perioperative problems related to intraocular Implantable Collamer Lens (ICL) implantation. Int Ophthalmol. 2022;42(11):3625–41. 10.1007/s10792-022-02355-w.
Sleiman K, Damaj A, Ali HM, Akiki D, Bleik J. Myopia prevalence and risk factors among medical trainees in Lebanon. Saudi J Ophthalmol. 2023;37(3):241–6. 10.4103/sjopt.sjopt_178_22. Published 2023 Mar 13.
Kamiya K, Shimizu K, Takahashi M, Ando W, Hayakawa H, Shoji N. Eight-Year Outcomes of Implantation of Posterior Chamber Phakic Intraocular Lens With a Central Port for Moderate to High Ametropia. Front Med (Lausanne). 2021;8:799078. 10.3389/fmed.2021.799078. Published 2021 Dec 16.
Moshirfar M, Bundogji N, Tukan AN, et al. Toric Implantable Collamer Lens for the Treatment of Myopic Astigmatism. Clin Ophthalmol. 2021;15:2893–906. 10.2147/OPTH.S321095. Published 2021 Jul 6.
Packer M. Evaluation of the EVO/EVO + Sphere and Toric Visian ICL: Six Month Results from the United States Food and Drug Administration Clinical Trial. Clin Ophthalmol. 2022;16:1541–53. 10.2147/OPTH.S369467. Published 2022 May 21.
Deshpande K, Shroff R, Biswas P, et al. Phakic intraocular lens: Getting the right size. Indian J Ophthalmol. 2020;68(12):2880–7. 10.4103/ijo.IJO_2326_20.
Sanders DR, Doney K, Poco M, ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004;111(9):1683–92. 10.1016/j.ophtha.2004.03.026.
Wannapanich T, Kasetsuwan N, Reinprayoon U. Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes. Clin Ophthalmol. 2023;17:969–80. 10.2147/OPTH.S379856. Published 2023 Mar 24.
Packer M. Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens. Clin Ophthalmol. 2016;10:1059–77. 10.2147/OPTH.S111620. Published 2016 Jun 9.
Miao H, Chen X, Tian M, Chen Y, Wang X, Zhou X. Refractive outcomes and optical quality after implantation of posterior chamber phakic implantable collamer lens with a central hole (ICL V4c). BMC Ophthalmol. 2018;18(1):141. Published 2018 Jun 14. 10.1186/s12886-018-0805-3.
Yang W, Zhao J, Sun L, et al. Four-year observation of the changes in corneal endothelium cell density and correlated factors after Implantable Collamer Lens V4c implantation. Br J Ophthalmol. 2021;105(5):625–30. 10.1136/bjophthalmol-2020-316144.
Hwang HB, Lyu B, Yim HB, Lee NY. Endothelial Cell Loss after Phacoemulsification according to Different Anterior Chamber Depths. J Ophthalmol. 2015;2015:210716. 10.1155/2015/210716.
Islam QU, Saeed MK, Mehboob MA. Age related changes in corneal morphological characteristics of healthy Pakistani eyes. Saudi J Ophthalmol. 2017;31(2):86–90. 10.1016/j.sjopt.2017.02.009).
Tang Y, Xu J, Chen J, Lu Y. (2020). Long-Term Destiny of Corneal Endothelial Cells in Anterior Chamber Intraocular Lens-Implanted Eyes. Journal of Ophthalmology. 2020. 1–6. 10.1155/2020/5967509.
Kocová H, Vlková E, Michalcová L, Rybárová N, Motyka O. Incidence of cataract following implantation of a posterior-chamber phakic lens ICL (Implantable Collamer Lens) - long-term results. Výskyt katarakty po implantaci zadněkomorové fakické čočky ICL - dlouhodobé výsledky. Cesk Slov Oftalmol. 2017;73(3):87–93.
Fujisawa K, Shimizu K, Uga S, et al. Changes in the crystalline lens resulting from insertion of a phakic IOL (ICL) into the porcine eye. Graefes Arch Clin Exp Ophthalmol. 2007;245(1):114–22. 10.1007/s00417-006-0338-y.
Kojima T, Kitazawa Y, Nakamura T et al. Prospective Randomized Multicenter Comparison of the Clinical Outcomes of V4c and V5 Implantable Collamer Lenses: A Contralateral Eye Study. J Ophthalmol. 2018;2018:7623829. Published 2018 Sep 5. 10.1155/2018/7623829.
Zhang H, Gong R, Zhang X, Deng Y. Analysis of perioperative problems related to intraocular Implantable Collamer Lens (ICL) implantation. Int Ophthalmol. 2022;42(11):3625–41. 10.1007/s10792-022-02355-w.
Rodríguez-Calvo-de-Mora M, Rocha-de-Lossada C, Rodríguez-Vallejo M, Zamora-de-la-Cruz D, Fernández J. Retinal detachment after refractive lens exchange: A narrative review. Arch Soc Esp Oftalmol (Engl Ed). 2023;98(9):507–20. 10.1016/j.oftale.2023.06.013.
Barraquer C, Cavelier C, Mejía LF. Incidence of retinal detachment following clear-lens extraction in myopic patients. Retrospective analysis. Arch Ophthalmol. 1994;112(3):336–9. 10.1001/archopht.1994.01090150066025.

No competing interests reported.

Download PDF

Version 1

posted

You are reading this latest preprint version

Implantable Collamer Posterior Chamber Intraocular Lenses: Effectiveness, Safety and Perioperative problems in a sample of Lebanese population

Status:

Version 1

Abstract

1. INTRODUCTION

2. METHODOLOGY

2.1. Study population:

2.2. Preoperative evaluation:

2.3. Selection and sizing of the ICL:

2.4. Surgical procedure:

2.5. Postoperative follow up:

2.6. Statistical analysis:

3. RESULTS

3.1. Sociodemographic and characteristics of the participants

3.2. Repeated measures ANOVA at 1 and 2 years of follow-up respectively:

3.3. Correlations of ACD:

3.4. Mean Values of ECC:

3.5. Complications:

4. DISCUSSION

5. LIMITATIONS

6. CONCLUSION

Declarations

Competing interests:

Funding:

Author Contribution

Acknowledgements:

Availability of data and materials:

References

Additional Declarations

Status:

Version 1