Over the past 10-15 years, the use of scleral lenses has dramatically increased due to the improvement in comfort and visual stability that the lenses provide, as well as the development of improved and easier-to-fit designs. Therapeutic optometrists and ophthalmologists use these medical devices for individuals suffering from irregular corneal astigmatism and in ocular surface diseases. As many as 25% of practitioners believe that the lens modality has emerged as a reasonable option for normal eyes which consists of more than 38 million contact lens wearers worldwide.
With the expansion of scleral lens use comes the need and opportunity to understand and communicate effectively regarding their safety and efficacy. Safety profiles of scleral lenses have begun to be established, but a critical benchmark to contact lens safety, established for all other types of contact lenses, is still missing from the literature: the incidence of microbial keratitis (MK). In the past several years, reports of MK have indeed emerged, although they exist only as case reports and no full-scale investigation into risk factors/confounding variables has been done.
The Consortium of Researchers Investigating Sclerals (CoRIS) is a group of practitioners who came together at GSLS 2020, who have established a mission to answer ‘big picture’ questions about scleral lenses that require a large dataset from a variety of diverse practices and demographics. At this first meeting in 2020, it was decided that the incidence of MK in scleral lenses, while expected to be low (specific estimate is 15-20 per 10,000 patient-years), is an essential metric to contribute to the safety profile of the lenses. The Multicenter Collection of Scleral Lens Outcomes (MC-SLO) study has been designed by members of the CoRIS group over the past two years, and funding to answer this question was obtained through the 2022 Clinical Research Award ($100,000) from the American Academy of Optometry.
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