Long-term Comparison of Vault and Complications of Implantable Collamer Lens with and without a Central Hole for High Myopia Correction: 5 Years

ABSTRACT

Purpose

To investigate the long-term safety, efficacy, stability, vault, and complications of implantable collamer lens with (ICL V4c) and without (ICL V4) a central hole for correcting high myopia.

Methods

78 eyes (40 patients) underwent ICL V4c implantation and 78 eyes (48 patients) underwent ICL V4 implantation were enrolled. They were followed up for 5 years of the uncorrected and corrected distance visual acuity, spherical equivalent (SE), axial length, intraocular pressure, endothelial cell density and vault.

ResuIts

The safety indices of the ICL V4c and V4 groups at 5 years were 1.25 ± 0.40 and 1.31 ± 0.40, respectively (P = .353). The efficacy indices were 0.90 ± 0.29 and 1.00 ± 0.44, respectively (P = .098). The preoperative, 1 month and 5 year postoperative logMAR UDVAs were respectively 1.54 ± 0.48, 0.11 ± 0.17, and 0.20 ± 0.26 in the V4c group and 1.56 ± 0.44, 0.14 ± 0.19, and 0.22 ± 0.26 in the V4 group (P = .703, 0.329, 0.585). The logMAR CDVAs were resepectively 0.13 ± 0.18, 0.02 ± 0.11, and 0.05 ± 0.16 in the V4c group and 0.18 ± 0.22, 0.05 ± 0.14, and 0.09 ± 0.21 in the V4 group (P = .128, 0.169, 0.229). The SE were resepectively −15.10 ± 4.32 D, −0.71 ± 1.31 D and −1.65 ± 1.30 D in the V4c group and −15.44 ± 3.51 D, −0.61 ± 1.12 D and −1.40 ± 1.30 D in the V4 group (P = .585, 0.637, 0.296). The mean vault reduced by 97.31 ± 136.61 μm in the V4c group and by 99.74 ± 245.83 μm in the V4 group. Three eyes (3.85%) with mid-periphery anterior subcapsular opacification in the V4c group and two (2.56%) with cataract, one (1.28%) with central anterior subcapsular opacification in the V4 group were observed. The CDVA of 20/40 was obtained in the two cataract eyes after phacoemulcification and intraocular lens implantation.

Conclusion

Long-term ICL V4c and ICL V4 implantations are safe, effective, and stable for high myopia correction. ICL V4c can potentially reduce the risk of lens opacification and may be more tolerant to low vault than ICL V4.

KEYWORDS:

• Posterior chamber phakic intraocular lens implantation
• high myopia
• ICL V4C
• ICL V4
• vault

Disclosure statement

No potential conflict of interest was reported by the author(s).

Contributors

The authors were involved in the conception or design of the work, the acquisition, analysis or interpretation of data for the work (XC, XQW, YlX, MRC, TH, XYW, XTZ); drafting the work or revising it critically for important intellectual content (XC, XQW); final approval of the version to be published (XC, XQW, YlX, MRC, TH, XYW, XTZ); agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved (XC, XQW, YlX, MRC, TH, XYW, XTZ).

Patient consent

Obtained.

Ethics approval

Ethics Committee of the Fudan University Eye Ear Nose and Throat Hospital (No. 2016038).

Data sharing statement

Data and materials are available upon request from the corresponding author at [email protected].

Additional information

Funding

1) National Natural Science Foundation of China [Grant No. 81770955]2) Joint research project of new frontier technology in municipal hospitals [Grant No. SHDC12018103]3) Project of Shanghai Science and Technology [Grant No. 20410710100]4) Major clinical research project of Shanghai Shenkang Hospital Development Center [Grant No. SHDC2020CR1043B]5) Project of Shanghai Xuhui District Science and Technology [Grant No. 2020-015]6) Shanghai Science and Technology Commission [Grant No. 19140900700]