Purpose: To evaluate the clinical results of a new scleral lens design with a bitangential (nonrotationally symmetrical) periphery.
Methods: All the necessary data were obtained during the 1-year study period. The bitangential scleral lenses were fitted and monitored according to a standardized fitting methodology. They were cut by precise submicron lathing from high-oxygen-permeable materials (including 10 scleral lenses from Menicon Z material). Subjective performance, visual acuity, and scleral lens–fitting characteristics were recorded after a median of 9.4 weeks (range, 3 weeks to 1 year).
Results: Diagnoses in the 213 eyes (in 144 patients) were keratoconus (n = 121 eyes; 56.8%), ocular surface diseases (n = 31 eyes; 14.6%), penetrating keratoplasty (n = 29 eyes; 13.6%), and other forms of irregular astigmatism (n = 28 eyes; 13.1%). Many patients (164 lenses; 77.0%) gave high ratings for comfort. The most common diameter was 20.0 mm (162 lenses; 76.1%) (range, 18.5 to 21.5 mm). Median decimal best-corrected visual acuity with the bitangential scleral lenses was 0.8 (equivalent to Snellen 20/25) (range, 0 to 1.5). Most bitangential scleral lenses showed good fitting characteristics: optimal values were seen for lens movement (208 lenses; 97.7%) and lens position (208 lenses; 97.7%). Median central corneal clearance was 0.2 mm; clearances differed in the four peripheral directions. The median stabilization axis was 140 degrees (range, 0 to 180 degrees) in the right eyes and 60 degrees (range, 0 to 180 degrees) in the left eyes.
Conclusions: The bitangential scleral lens–fitting and performance characteristics were clear and effective for the health professional and the patient. The high-oxygen-permeable material Menicon Z may, in theory, be of benefit to corneas with a high oxygen demand.