Implantable collamer lens V4b and V4c for correction of high myopia

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Abstract

Purpose

To evaluate the visual outcome and intraocular pressure changes after Visian Implantable Collamer Lens (ICL) implantation V4b and V4c (with central hole) for correction of high myopia.

Methods

A prospective, consecutive, interventional comparative case series of V4b and V4c ICL implantation was done in high myopic patients who were unsuitable for laser vision. The main outcome measures studied were uncorrected and corrected distant visual acuity (UDVA, CDVA), ICL vault, intraocular pressure (IOP), endothelial cell count (ECC), and development of subcapsular lens opacities. The patients were evaluated at postoperative 1,3,6, and 9 months.

Results

A total of 62 eyes of 32 patients (24.56 ± 4.8 years) underwent V4b ICL implantation (21 non-toric, 41 toric ICL-TICL) with intraoperative peripheral iridectomy (PI), and 10 eyes of 5 patients (26.13 ± 3.8 years) had implantation of V4c ICL (4 non-toric, 6 TICL). The mean preoperative manifest spherical equivalent (MSE) was −9.98 ± 2.8 D and −9.14 ± 2.4 D in the V4b and V4c groups, respectively, which reduced to postoperative values of −0.24 ± 1.3 D and −0.2 ± 1.18 D, respectively. At the end of 9 months follow-up, mean ECC loss was 6.4% and 6.1%, mean vault was 573.13 ± 241.13 μ, and 612 ± 251.14 μ, respectively, in the V4b and V4c groups. Anterior subcapsular opacities were present in 6.9% and 3.14% of eyes with V4b and V4c groups, respectively. Four eyes from V4b (9.75%) and 1 eye from V4c (16.66%) had rotation of more than 30° and required realignment surgery, which was done successfully. Two eyes (3.22%) with V4b ICL implantation had high postoperative IOP (>35 mm Hg) due to blocked PI and required Nd:Yag laser iridotomy, which was done with successful control of IOP. The safety indices were 1.11 and 1.14, and efficacy indices were 1.4 and 1.5 in the V4b and V4c groups, respectively, at the end of 9 months.

Conclusion

ICL implantation is a safe and effective surgery for correction of high myopia. Implantation of ICL with a central hole showed negligible postoperative IOP fluctuations without a peripheral iridectomy.

Related collections

Most cited references 38

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United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.

K Doney, Monica Poco, Robert Sanders (2004)

To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL). Prospective nonrandomized clinical trial. Five hundred twenty-six eyes of 294 patients with between 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Implantation of the ICL. Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms. At 3 years, 59.3% had 20/20 or better VA, and 94.7% had 20/40 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emmetropia; 67.5% of patients were within 0.5 D and 88.2% were within 1.0 D of predicted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines. At 3 years postoperatively, 3 eyes (0.8%) decreased by >or=2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensitivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anterior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed nuclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6% reported dissatisfaction; 97.1% of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged after ICL surgery. Three-year results from this standardized, multicenter clinical investigation support the safety, efficacy, and predictability of ICL surgery to treat moderate to high myopic refractive errors.

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Implantable collamer posterior chamber intraocular lenses: a review of potential complications.

Marcus Paulo Fernandes Amarante, Roberta J. B. Jorge, Robert Montés-Micó … (2011)

To review the peer-reviewed literature reporting postoperative complications of the most recent models of Visian Implantable Collamer posterior chamber intraocular lenses (ICL, STAAR Surgical Co). A literature search of the PubMed database was performed to identify all articles related to ICL complications. Articles were obtained and reviewed to identify those that reported complications using the latest ICL designs. Cataract was the major postoperative complication reported: 136 (5.2%) in 2592 eyes. Of those, 43.4% (n=59) were reported within 1 year, 15.4% (n=21) between 1 and 3 years, and 35.3% (n=48) ≥ 3 years after ICL implantation. Twenty-one (15.4%) cataracts were reported as surgically induced, 46 (33.8%) eyes had poor vault (<200 μm), and cataract surgery was carried out in 27.9% (n=38) of eyes. Early acute intraocular pressure increase was also reported to be relatively frequent, whereas acute pupillary block was less frequent and mostly resolved with additional iridotomies. A total of 42 ICLs were explanted due to cataract and IOP. Reported endothelial cell loss varied from 9.9% at 2 years to 3.7% 4 years postoperatively. This loss was reported to be more pronounced within the first 1 to 2 years, with stability or lower progression after that time. The majority of reported complications after ICL implantation are cataract formation. The improvements in lens geometry and more accurate nomograms applied to the selection of the lens to be implanted, in addition to the surgeon's learning curve, might be factors in the decreased occurrence of postoperative complications reported currently. Copyright 2011, SLACK Incorporated.