Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: A 2-year randomised clinical trial.

PURPOSE: To compare axial elongation (AE) and treatment zone (TZ) characteristics in children wearing 6 mm or 5 mm back optic zone diameter (BOZD) orthokeratology (ortho-k) lenses over 2 years. METHODS: Forty-five (6 to <11 years of age) myopic (-4.00 to -0.75 D) children of Chinese ethnicity were randomly assigned to use the two different lens designs (23 and 22 wore the 6 and 5 mm lenses, respectively). Data collection was performed at baseline and every 6-months after commencing lens wear. RESULTS: After 24 months, subjects wearing lenses with a 5 mm BOZD achieved smaller TZ diameter (horizontal: 2.69 ± 0.28 vs. 3.84 ± 0.39 mm; vertical: 2.65 ± 0.22 vs. 3.42 ± 0.34 mm, p < 0.001) and less AE (0.15 ± 0.21 vs. 0.35 ± 0.23, p = 0.005) compared to those using the 6 mm design, with no difference in choroidal thickness (ChT) changes (p = 0.93). A significant increase in ChT, using pooled data analysis, was noted at the 6-month (11.8 ± 19.77 µm, p < 0.001) and 12-month (12.0 ± 23.7 µm, p = 0.004) visits, compared to baseline, indicating a transient change in ChT. Significant associations were noted, using linear mixed models, between AE and the TZ diameters (p < 0.003) after adjusting for baseline data. A very weak association was found between ChT changes and AE, with the effect size close to zero. CONCLUSIONS: Smaller BOZD ortho-k lenses resulted in a smaller TZ diameter, which was associated with less AE after 2 years of treatment. The changes in ChT played a very weak role, suggesting that other factors may contribute more to the reduced AE in subjects wearing lenses having a smaller BOZD.