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Clinical Performance of a New Bitangential Mini-scleral Lens

Otten, Henny M., BSc, FAAO1*; van der Linden, Bart J. J. J., PhD2; Visser, Esther-Simone, PhD1

Optometry and Vision Science: June 2018 - Volume 95 - Issue 6 - p 515–522
doi: 10.1097/OPX.0000000000001228
Original Investigations

SIGNIFICANCE New bitangential mini-scleral lens designs provide a highly precise fit, follow the scleral shape, are comfortable to wear, and can correct residual astigmatism. This new scleral lens design complements the arsenal of medical contact lenses available to eye care practitioners.

PURPOSE The aim of this study was to evaluate the subjective and objective performance of a new mini-scleral lens design with a bitangential periphery.

METHODS In this observational study, data were collected for up to 15 months (median, 84 days; interquartile range, 76 days) from the left eyes of 133 patients fitted with this newly designed lens. Data were recorded during regular visits at Visser Contact Lens Practice's scleral lens clinics: diagnosis, clinical indication for scleral lenses, previous contact lens type, subjective performance, horizontal visible iris diameter, corrected distance visual acuity, and scleral lens fitting characteristics.

RESULTS The most common indication was keratoconus (45%), followed by irregular astigmatism (22%), keratoplasty (16.5%), ocular surface disease (13.5%), and other forms of irregular astigmatism (3%). The majority of patients (79%) scored comfort as either a 4 or 5 (out of 5), and 82% wore their lenses 12 hours or longer a day. Most lenses (81%) had a diameter of 16 mm (median, 16 mm; range, 15.5 to 17 mm) and were composed of Boston XO2 (46%), Menicon Z (44%), Boston XO (9%), or Boston Equalens II (1%). The median corrected distance visual acuity was 0.022 logarithm of the minimal angle of resolution (interquartile range, 0.155). The fitting characteristics revealed optimal values for centration and movement in 91% and 83%, respectively. Finally, the median stabilization axis was 50 degrees.

CONCLUSIONS New mini-scleral lenses with bitangential peripheral geometry yield satisfactory clinical results and good subjective performance and are therefore an effective option for managing patients who have irregular astigmatism or other corneal pathology.

1Visser Contact Lens Practice, Nijmegen-Utrecht, The Netherlands

2NKL Contactlenzen, Emmen, The Netherlands *

Submitted: July 3, 2017

Accepted: April 5, 2018

Funding/Support: None of the authors have reported funding/support.

Conflict of Interest Disclosure: HMO is employed at Visser Contact Lens Practice, therefore no personal financial interest in the product. BJJJvdL is a technical managing director and product design engineer employed by NKL Contactlenzen. The lenses are manufactured by NKL Contactlenzen, which is the owner of the designs. Because of neither having shares in the company nor having a royalty agreement, there is no personal financial interest in the products. E-SV is co-owner at Visser Contact Lens Practice, Nijmegen, The Netherlands. Visser Contact Lens Practice has a royalty agreement on the lens in the article.

Author Contributions: Conceptualization: HMO, BJJJvdL; Data Curation: HMO; Formal Analysis: HMO, BJJJvdL; Investigation: HMO; Methodology: HMO, E-SV; Project Administration: HMO; Resources: BJJJvdL; Software: BJJJvdL; Supervision: E-SV; Validation: E-SV; Visualization: HMO, BJJJvdL; Writing – Original Draft: HMO; Writing – Review & Editing: BJJJvdL, E-SV.

© 2018 American Academy of Optometry