One-step viscoelastic agent technique for ICL V4c implantation for myopia

AIM: To investigate the safety and efficacy of using a one-step viscoelastic agent technique for posterior chamber phakic implantable collamer lens with a central hole (ICL V4c) implantation for myopia correction. METHODS: The one-step viscoelastic agent technique for ICL V4c implantation was used in 100 eyes of 52 patients. Refractive outcomes, intraocular pressure (IOP), corneal endothelial cell, and corneal densitometry values were evaluated at 1d, 1wk, 1 and 3mo postoperatively. RESULTS: All the surgeries were uneventful. No corrected distance visual acuity was lost after 3mo. IOP was 16.12±3.18 mm Hg before surgery, and 14.74±3.08 mm Hg at 1d and 14.50±2.56 mm Hg at 3mo after surgery (P<0.05). Corneal endothelial cell density was 2580±242 cell/mm², the coefficient of variation in cell size was 42.11%±7.92%, and the percentage of hexagonal cells was 40.98%±9.46% before surgery. No significant difference was found when these outcomes were compared between the studied time points (P>0.05). The corneal densitometry values of the central 2 mm and 2 to 6 mm areas showed similar regularities. After surgery, the values significantly increased at 1d, then decreased to the preoperative values at 1wk, and then continued to decrease at 3mo (P<0.05). CONCLUSION: The one-step viscoelastic agent technique for ICL V4c implantation is found to be safe and effective for myopia correction and causes little disturbance to the cornea.

In vivo optical quality of posterior-chamber phakic implantable collamer lenses with a central port

Background The aim of this review is to summarize the optical quality results in patients following the implantation of the V4c implantable collamer lens with a central port (ICL, STAAR Surgical Inc.). Main text A literature search in several databases was carried out to identify those publications, both prospective, retrospective and/or comparative with other refractive surgery procedures, reporting optical outcomes of patients who were implanted with the V4c ICL model. A total of 17 clinical studies published between 2012 and 2021 were included in this review. A detailed analysis of the available data was performed including number of eyes, follow-up and preoperative spherical equivalent. Specifically, the review focused on several optical parameters including higher-order aberrations (HOAs), modulation transfer function (MTF) cut-off frequency and Strehl ratio. This review encompassed a total of 817 eyes measured using different optical devices based on Hartmann-Shack, retinal image quality measurement and ray-tracing technologies at different follow-ups. Conclusions The outcomes found in this review lead us to conclude that the ICL V4c model provides good optical quality, by means of different metrics, when implanted.

Long-term evaluation of anterior lens density after implantable collamer lens V4c implantation in patients with myopia over 40 years old

PurposeTo investigate the long-term safety and efficacy of implantable collamer lens (ICL) V4c implantation and changes in the anterior lens density (ALD) in patients with myopia ≥40 years of age.MethodsThis prospective study included 104 eyes of 52 patients >40 years of age before ICL V4c implantation. Spherical equivalent (SE), uncorrected distance visual acuity, corrected distance visual acuity (CDVA), intraocular pressure, endothelial cell density, anterior chamber depth, anterior chamber volume and anterior chamber angle preoperatively, at 1 and 3 months, and at 3 years postoperatively were recorded. Pentacam HR was used to analyse ALD changes at a depth of 0.5, 1.0 and 1.5 mm within a 3 mm diameter range around the pupil’s centre.ResultsThe overall follow-up was uneventful at 42±7.1 months; the safety index at last follow-up was 1.26±0.35 and the efficacy index was 0.91±0.41. No eye lost the Snellen line of CDVA, 76% of the eyes had an increase in CDVA for ≥1 line and 62% had an SE within ±0.50 dioptre. The increase in ALD at 0.5, 1 and 1.5 mm was 16.52%±10.46%, 16.72%±9.85% and 17.28%±11.93%, respectively. Preoperative, 1-month and 3-month postoperative ALDs showed correlations with SE and age, and ALD at last follow-up was correlated only with age. There was no correlation between ALD and any other parameters.ConclusionICL V4c shows long-term safety and efficacy in people ≥40 years of age. ALD increased in such patients, which may be related to age and SE.

Comparison of Accommodation and Accommodative Micro-Fluctuation After Implantable Collamer Lens and LASIK Surgery for Myopia

Background: To longitudinally analyze and compare the accommodative micro-fluctuation (MFs) and accommodative function between myopic patients after implantable collamer lens (ICL) implantation and laser in situ keratomileusis (LASIK).Methods: Patients with good corrected visual acuity (20/20 or better) that underwent ICL (V4c) and LASIK for myopic-correction (ranging from -3.50 to -8.50 D) were recruited. Refraction, amplitude of accommodation (AMP), accommodative lags, high-order aberrations (HOAs), and MFs were recorded before surgery and 1 and 3 months after surgery. The ACOMEREF automatic refractor was used to measure the high-frequency component (HFC) of the MFs, which suggested tension of the ciliary muscle.Results: The study comprised 120 eyes. At 3 months after surgery, the manifest refractive spherical equivalent of the ICL and LASIK groups were -0.11 and -0.09 D, respectively (p = 0.46). HFC values were significantly higher at 1 month (p = 0.03) and 3 months postoperatively (p = 0.03) in the ICL group compared to that in the LASIK group. The ocular HOAs of the ICL group was 1.08 ± 0.43 μm, which was lower than the LASIK group 1.45 ± 0.54 μm (p = 0.01). No significant differences in AMP and accommodative lags between groups were noted at 3 months postoperatively. There was a positive correlation between HFC and vault of the ICL lens (r2 = 0.14, p = 0.005). There were no correlations between HFC and HOAs and postoperative MRSE in the two groups (all p﹥0.05).Conclusions: The HFC increased significantly after ICL implantation compared to laser in situ keratomileusis for myopic correction, which indicated increased tension of the ciliary muscle, and had a positive correlation on the vault of the ICL lens; However, studies with longer follow-up time and more structural evaluation are needed.

Peripheral Anterior Chamber Depth and Angle Measurements Using Pentacam After Implantation of Toric and Non-toric Implantable Collamer Lenses

Purpose: To evaluate the characteristics of peripheral anterior chamber measurements by Pentacam after posterior implantable collamer lenses (ICL) and toric ICL (TICL) with central hole (V4c) implantation.Methods: Prospective, non-randomized consecutive case series. Forty-six patients undergoing ICL implantation in one eye (Group A) and identically sized TICL in the contralateral eye (Group B) in the Refractive Surgery Center of Eye and ENT Hospital of Fudan University were prospectively included. According to ICL/TICL size, these eyes were further divided into four subgroups. Peripheral anterior chamber depth (PACD) and angle (ACA) in nasal and temporal sides were measured using Pentacam pre-operatively and 12-month post-operatively.Results: The safety indices were 1.34 ± 0.32 and 1.25 ± 0.16 and the efficacy indices were 1.20 ± 0.24 and 1.19 ± 0.19 for ICL and TICL groups, respectively. There was no significant difference in pre-operative PACD or ACA between the two groups. Post-operative PACD and ACA were significantly lower than pre-operative values. Variations of PACD and ACA of TICL group were significantly larger than those of ICL group. The change of ACA for 13.2 mm lenses was significantly larger than that of 12.6 mm lenses. Pre-operative CACD and vault were significantly associated with post-operative PACD, while pre-operative ACA and vault were significantly associated with post-operative ACA.Conclusions: Variations of PACD and ACA were greater in eyes after TICL (V4c) implantation compared with identically sized ICL (V4c) implantation and with larger size than smaller size lens implantation. Pre-operative anterior chamber structure and vault affect post-operative PACD and ACA.

Long-Term Assessment of the Quality of Visually-Related Daily Activities After ICL (V4c) Implantation for Myopia and Myopic Astigmatism

This study was performed to evaluate the long-term quality of visually related daily activities after Central Hole Collamer Lens Implantation to treat myopia and astigmatism. This study included 46 eyes (in 23 patients) that received ICL-V4c implantation. The follow up time was at least 24 months. Moreover, patient satisfaction related to daily vision activities were recorded at 6 and 24 months. The parameters measured included uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, eye axis, intraocular pressure (IOP), endothelial cell density (ECD) and vault. The mean spherical equivalents were –0.14 ± 0.21 D and –0.12 ± 0.33 D at 6 and 24 months after surgery, respectively. All the eyes were better postoperative (UCVA) than preoperative (BCVA). The BCVA at 6 and 24 months after implantation was –0.03 ± 0.08 LogMAR and –0.03 ± 0.11 LogMAR, which is statistically better (P = 0.031) than the pre-operation value 0.07 ± 0.12 LogMAR. There was no significant (P > 0.05) difference between the pre-operation and post-operation ECD. At 24 months post-operation, 10% of the patients complained about difficulty driving at night; meanwhile, most patients expressed satisfaction or were very satisfied. Approximately 13% of the patients worried about long term safety and efficacy after the ICL-V4c implantation. Patients are very satisfied with daily related vision activities after ICL-V4c implantation.

Four-year observation of the changes in corneal endothelium cell density and the correlated factors after Implantable Collamer Lens V4c implantation

BackgroundTo evaluate the changes in corneal endothelium cell density (ECD) and the correlated factors after Implantable Collamer Lens (ICL) V4c implantation.MethodsIn this retrospective, consecutive study, 48 eyes of 25 patients with myopia who underwent ICL V4c implantation were enrolled. Patients were followed up for at least 4 years, during which manifest refraction, uncorrected distance visual acuity, corrected distance visual acuity (CDVA), intraocular pressure, ECD, anterior chamber depth, anterior chamber volume (ACV), anterior chamber angle (ACA), vault and distance from the corneal endothelium to the central ICL (C-ICL) were measured. Spearman’s correlation analysis was used to identify variables correlated with changes in ECD, and generalised estimating equation model adjusting within-patient intereye correlations was used to predict changes in ECD.ResultsAll surgeries were performed safely with no complications during follow-up (average 52±2.9 months). Safety and efficacy indices were 1.23±0.22 and 1.04±0.16, respectively. No eyes had decreased CDVA, and 67% gained one or more lines. Further, 79% were within ±0.50 D, and 100% were within ±1.0 D of the attempted refraction. Additionally, a 4.03%±2.2% reduction in ECD compared with the preoperative value was observed at the last follow-up visit. Changes in ECD were significantly correlated with vault, C-ICL, change in ACA and change in ACV. Vault was the most significant factor for changes in ECD.ConclusionsICL V4c implantation is safe and effective for myopia correction. Anterior segment biometric parameters including the vault, ACA and C-ICL may influence changes in ECD; specifically, the vault plays a major role.

Phakic Posterior Chamber Intraocular Lens with a Central Hole in Treating Patients with Moderate to High Myopia: A Meta-Analysis

Purpose. To evaluate the efficacy of phakic posterior chamber intraocular lens with a central hole (ICL V4c) in treating patients with moderate to high myopia. Methods. PubMed, Embase, Cochrane Library, Clinical Trial, China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and China Science Periodical Database (CSPD) were searched online. The search included publications from the building of the library until December 2018. All randomized controlled trials containing moderate to high myopia treated by phakic posterior chamber intraocular lens with a central hole were collected. Literature search, screening literature, data extraction, and quality evaluation were independently performed by two reviewers. Meta-analysis was performed using RevMan 5.3 software. Results. Meta-analysis results based on five randomized controlled trials showed that ICL V4c and ICL without a central hole had similar UCVA results (SMD = 0.08, 95% CI (−0.71, 0.88), P=0.84), SE (SMD = −0.18, 95% CI (−0.52, 0.15), P=0.29), BCVA (SMD = −0.27, 95% CI (−0.93, 0.40), P=0.43), and IOP (SMD = 0.03, 95% CI (−0.24, 0.30), P=0.84), and the difference was not statistically significant. In addition, no complications that could jeopardize vision occurred. Conclusions. Implanting ICL V4c in patients with moderate to high myopia is safe and effective.