Toric Implantable Collamer Lens for the Treatment of Myopic Astigmatism

Abstract

Purpose

To report visual outcomes following surgical correction of myopic astigmatism with Visian Toric implantable collamer lens (ICL) (STAAR Surgical, Monrovia, CA, USA) at a single tertiary refractive center in the United States.

Patients and Methods

Toric ICL was implanted in 96 eyes (55 patients) with mean preoperative sphere of −8.98 ± 3.04 diopters (D) and cylinder of −2.67 ± 1.02 D from December 2018 to February 2021. Primary visual outcomes of efficacy, safety, stability, predictability of refractive correction, and astigmatic analysis were reported at three and twelve months postoperatively. Secondary subjective outcomes included patient-reported dry eye symptoms and glare/halos at postoperative visits. Other secondary outcomes were biometric data and postoperative vault over time.

Results

At three and twelve months, 75 and 46 eyes were evaluated, respectively. At twelve months, the mean manifest refraction spherical equivalent (MRSE) was −0.23 ± 0.47 D with 93% achieving within ±1.00 D of target refraction. The manifest refractive cylinder (MRC) at twelve months was −0.73 ± 0.51 D, with 86% within ±1.00 D of target. Uncorrected distance visual acuity (UDVA) was 20/20 or better in 74% of eyes at twelve months. No patients lost ≥2 lines of corrected distance visual acuity (CDVA) at twelve months. The mean angle of error was −0.9 ± 10.2° at three months and −1.6 ± 12.8° at twelve months. One patient required bilateral lens rotation, four patients underwent secondary enhancement with LASIK/PRK, and seven patients underwent postoperative limbal relaxing incisions.

Conclusion

This initial single-site experience finds Toric ICL implantation for myopic astigmatism to be safe and effective. Patients can achieve markedly improved UDVA in a single surgery with stable vision over time and minimal adverse subjective symptoms.

Keywords:

• Toric ICL
• visian
• myopic astigmatism
• visual outcomes

Abbreviations

LASIK, laser-assisted in situ keratomileusis; PRK, photorefractive keratectomy; Toric ICL, Toric Implantable Collamer Lens; FDA, Food and Drug Administration; UBM, ultrasound biomicroscopy; D, Diopter; IOP, intraocular pressure; UDVA, uncorrected distance visual acuity; CDVA, corrected distance visual acuity; OCT, optical coherence tomography; YAG, Yttrium-Aluminum Garnet; PI, peripheral iridotomy; MRSE, manifest refraction spherical equivalent; MRC, manifest refractive cylinder; TIA, target induced astigmatism; SIA, surgically induced astigmatism; LRI, limbal relaxing incisions.

Ethics Approval and Informed Consent

All patients were fully informed and consented to treatment. Eight patients underwent off-label Toric ICL implantation due to age <21 years or >45 years and were consented and counseled appropriately. All methods and procedures followed the tenets of the Declaration of Helsinki and were approved by the Hoopes Vision Research Review Board. Biomedical Research Alliance of New York (Brany) Institutional Review Board (New York) approved this study.

Consent

This retrospective study using de-identified data has been approved by the Hoopes Vision Ethics Board and BRANY IRB #20-12-547-823 (New York, NY, USA). The study conforms with the Helsinki Declaration of 1964, as revised in 2013, concerning human and animal rights. The patients signed informed consent.

Acknowledgments

Special thanks to Anne Duong, Robert Thomson, and William West for their assistance with data acquisition, analysis, and management.

Author Contributions

All authors take responsibility for the integrity of the work, and have given final approval to the version to be published. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agreed to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This study was funded by an unrestricted grant from Research to Prevent Blindness (RPB), 360 Lexington Avenue, 22nd Floor New York, NY 10017. No support was received for the publication of this article.