Background:

Phakic intraocular lenses (pIOLs) have proven to be excellent substitutes for excimer laser keratorefractive surgery in certain situations. We aimed to assess the efficacy and safety of two pIOLs, the implantable collamer lens (ICL V4c) versus the implantable phakic contact lens (IPCL V2), for myopic correction.

Methods:

In this prospective randomized clinical trial, we allocated eligible eyes with myopia > - 6 diopters into IPCL or ICL implantation groups, each including 100 eyes of 100 individuals. Preoperative and postoperative assessments at 3, 6, and 12 months included measurements of the spherical equivalent (SE), uncorrected distance visual acuity (UCDVA), best-corrected distance visual acuity (BCDVA), intraocular pressure (IOP), maximum keratometry (K1), minimum keratometry (K2), mean keratometry (Kmean), anterior chamber depth (ACD), anterior chamber angle (ACA), and endothelial cell density (ECD).

Results:

The groups had comparable demographic characteristics and baseline visual and anatomical values (all P > 0.05). The UCDVA, BCDVA, and SE of the two groups were comparable at baseline and at all postoperative follow-up examinations (all P > 0.05). Both groups experienced significant improvements in UCDVA, BCDVA, and SE at three months postoperatively (all P = 0.001), and measurements remained stable for up to 12 months. Keratometry readings were comparable between the groups over the follow-up period and remained unchanged at all visits (all P > 0.05). The ACA in the ICL group was significantly decreased at three months postoperatively (P = 0.001) and then widened significantly at 6 and 12 months (both P = 0.001). In the IPCL group, the postoperative ACA was significantly decreased at three months (P = 0.001) and was comparable to that in the ICL group (P > 0.01). However, at the 6- and 12-month postoperative visits, the ACA was significantly narrower in the IPCL group than in the ICL group (both P = 0.001). The ACD in both groups was decreased at three months postoperatively (both P = 0.001) and remained stable until the end of the study. The ECD remained comparable between the groups at all postoperative visits (all P > 0.05). We did not observe a significant ECD reduction in either group at any postoperative follow-up visit (all P > 0.05). We encountered no serious complications in either group.

Conclusions:

ICL and IPCL had comparable safety and efficacy outcomes in terms of anterior chamber morphometrics, visual and refractive results, and corneal parameters. Further multicenter randomized clinical trials with longer follow-up periods, larger sample sizes, and measurement of additional anterior chamber and corneal morphometrics, vault, and other vision parameters are needed to verify these findings.