Skip to main content
SpringerLink
Log in

Clinical performance of a custom-designed soft contact lens in patients with keratoconus and intolerance to rigid contact lenses

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

This study evaluated the efficacy and safety of YOUSOFT® soft contact lens (CL) (TOMEY-CL) in patients with keratoconus and intolerance to rigid CLs.

Study design

Retrospective observational study.

Methods

Thirty-six eyes of 20 patients (14 men and 6 women) with keratoconus and rigid CL intolerance were included in the study. Four patients were unilateral. The mean age was 33.1 ± 11.7 (± standard deviation) years, the mean spherical refractive error was − 4.99

± 3.97 D, and the mean cylindrical refractive error was − 3.39 ± 2.13 D. The following examinations were performed at baseline and were repeated at every visit; refractometry, visual acuity, corneal topography and pachymetry with an anterior OCT system. Corneal endothelial cell density was evaluated at baseline and every 6 months. Slit-lamp examination was also performed to confirm the CL condition and ocular health at every visit.

Results

Seventeen patients (85%) were able to continue using the Yousoft. Among 3 patients (15%) who dropped out, 2 were dissatisfied with their visual outcomes and one had trouble with lens handling. Uncorrected visual acuity was 1.08 ± 0.43 (range: 0.22 to 2.00) logMAR at baseline, and best CL-corrected visual acuity was 0.01 ± 0.15 (range: − 0.18 to 0.40) logMAR, showing a significant improvement after wearing Yousoft (P < 0.0001). The endothelial cell density did not change significantly, with 2373 ± 482 at baseline and 2402 ± 464 cells/mm2 at the latest visit after lens prescription (P = 0.351). There were no severe complications such as corneal infiltrates or infectious keratitis throughout the study period.

Conclusions

This study showed the efficacy and acceptable safety of Yousoft for patients with keratoconus and intolerance to rigid CLs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984;28:293–322.

    Article  CAS  Google Scholar 

  2. Jinabhai A, Radhakrishnan H, Tromans C, O’Donnell C. Visual performance and optical quality with soft lenses in keratoconus patients. Ophthalmic Physiol Opt. 2012;32:100–16.

    Article  Google Scholar 

  3. Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiologic study of keratoconus. Am J Ophthalmol. 1986;101:267–73.

    Article  CAS  Google Scholar 

  4. Romero-Jimenez M, Santodomingo-Rubido J, Wolffsohn JS. Keratoconus: a review. Cont Lens Anterior Eye. 2010;33:157–66.

    Article  Google Scholar 

  5. Georgiou T, Funnell C, Cassels-Brown A, O’Conor R. Influence of ethnic origin on the incidence of keratoconus and associated atopic disease in Asians and white patients. Eye. 2004;18:379.

    Article  CAS  Google Scholar 

  6. Weed K, MacEwen C, Giles T, Low J, McGhee C. The Dundee University Scottish Keratoconus study: demographics, corneal signs, associated diseases, and eye rubbing. Eye. 2008;22:534–41.

    Article  CAS  Google Scholar 

  7. Pearson A, Soneji B, Sarvananthan N, Sandford-Smith J. Does ethnic origin influence the incidence or severity of keratoconus? Eye. 2000;14:625–8.

    Article  Google Scholar 

  8. Kuo IC, Broman A, Pirouzmanesh A, Melia M. Is there an association between diabetes and keratoconus? Ophthalmology. 2006;113:184–90.

    Article  Google Scholar 

  9. Munir SZ, Munir WM, Albrecht J. Estimated prevalence of keratoconus in the United States from a large vision insurance database. Eye Contact Lens. 2021;47:505–10.

    Article  Google Scholar 

  10. Davidson AE, Hayes S, Hardcastle AJ, Tuft SJ. The pathogenesis of keratoconus. Eye (Lond). 2014;28:189–95.

    Article  CAS  Google Scholar 

  11. Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998;42:297–319.

    Article  CAS  Google Scholar 

  12. Vinciguerra R, Pagano L, Borgia A, Montericcio A, Legrottaglie EF, Piscopo R, et al. Corneal cross-linking for progressive keratoconus: up to 13 years of follow-up. J Refract Surg. 2020;36:838–43.

    Article  Google Scholar 

  13. Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: a review. Surv Ophthalmol. 2015;60:459–80.

    Article  Google Scholar 

  14. Mohammadpour M, Heidari Z, Hashemi H. Updates on managements for keratoconus. J Curr Ophthalmol. 2017;30:110–24.

    Article  Google Scholar 

  15. Atalay E, Özalp O, Yıldırım N. Advances in the diagnosis and treatment of keratoconus. Ther Adv Ophthalmol. 2021. https://doi.org/10.1177/25158414211012796.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Gore DM, Shortt AJ, Allan BD. New clinical pathways for keratoconus. Eye (Lond). 2013;27:329–39.

    Article  CAS  Google Scholar 

  17. Weed KH, Macewen CJ, McGhee CN. The Dundee University Scottish Keratoconus Study II: a prospective study of optical and surgical correction. Ophthalmic Physiol Opt. 2007;27:561–7.

    Article  CAS  Google Scholar 

  18. Zadnik K, Barr JT, Edrington TB, Everett DF, Jameson M, McMahon TT, et al. Baseline findings in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study. Invest Ophthalmol Vis Sci. 1998;39:2537–46.

    CAS  PubMed  Google Scholar 

  19. Romero-Jiménez M, Santodomingo-Rubido J, González-Meijóme JM, Flores-Rodriguez P, Villa-Collar C. Which soft lens power is better for piggyback in keratoconus? Part II. Cont Lens Anterior Eye. 2015;38:48–53.

    Article  Google Scholar 

  20. Kloeck D, Koppen C, Kreps EO. Clinical outcome of hybrid contact lenses in keratoconus. Eye Contact Lens. 2021;47:283–7.

    Article  Google Scholar 

  21. Fuller DG, Wang Y. Safety and efficacy of scleral lenses for keratoconus. Optom Vis Sci. 2020;97:741–8.

    Article  Google Scholar 

  22. Fernandez-Velazquez FJ. Kerasoft IC compared to Rose-K in the management of corneal ectasias. Cont Lens Anterior Eye. 2012;35:175–9.

    Article  Google Scholar 

  23. Su S, Johns L, Rah MJ, Ryan R, Barr J. Clinical performance of KeraSoft® IC in irregular corneas. Clin Ophthalmol. 2015;9:1953–64.

    CAS  PubMed  PubMed Central  Google Scholar 

  24. Sapkota K, Lira M, Martin R, Bhattarai S. Ocular complications of soft contact lens wearers in a tertiary eye care centre of Nepal. Cont Lens Anterior Eye. 2013;36:113–7.

    Article  Google Scholar 

  25. Kumar P, Bandela PK, Bharadwaj SR. Do visual performance and optical quality vary across different contact lens correction modalities in keratoconus? Cont Lens Anterior Eye. 2020;43:568–76.

    Article  Google Scholar 

Download references

Acknowledgements

This research was supported in part by an unrestricted investigator-initiated grant from TOMEY-CL Co. Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan

    Takahiro Hiraoka, Gaku Kiuchi, Reia Hiraoka & Tetsuro Oshika

Authors
  1. Takahiro Hiraoka
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gaku Kiuchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Reia Hiraoka
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Tetsuro Oshika
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Takahiro Hiraoka.

Ethics declarations

Conflicts of interest

T. Hiraoka, Lecture fee (SEED, Menicon, Johnson & Johnson, Alpha), Support for attending meetings (SEED, Menicon, Johnson & Johnson, Alpha); G. Kiuchi, None; R. Hiraoka, None; T. Oshika, Grants (Alcon, HOYA, Johnson & Johnson, Santen, Senju, KOWA, Otsuka, Pfizer, TOMEY, Topcon, Futaba), Consulting fees (Alcon, Johnson & Johnson, Santen, Logic & Design, Topcon, Mitsubishi Tanabe), Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Alcon, Glaukos, HOYA, Japan Focus, Johnson & Johnson, KOWA, Otsuka, Santen, Senju, TOMEY, Novartis, Inami, Logic & Design).

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Corresponding Author: Takahiro Hiraoka

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hiraoka, T., Kiuchi, G., Hiraoka, R. et al. Clinical performance of a custom-designed soft contact lens in patients with keratoconus and intolerance to rigid contact lenses. Jpn J Ophthalmol 66, 350–357 (2022). https://doi.org/10.1007/s10384-022-00924-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10384-022-00924-1

Keywords

Search

Navigation