Orthokeratology in adults and factors affecting success: Study design and preliminary results.

Objective: To report the study design and one month's preliminary results of a randomized, single-masked, one-year prospective study of orthokeratology (ortho-k) in adults wearing lenses of different compression factors.
Methods: Adults aged 18-38 years, with myopia of -0.75 to -5.00 D and astigmatism < 1.50 D, were recruited and randomly assigned into two groups: a conventional compression factor or Jessen Factor (CCF) group (compression factor = 0.75 D) and an increased (extra 1.00D) compression factor (ICF) group. Clinical outcomes, including spherical equivalent refraction (SER) reduction, visual acuity, corneal hysteresis (CH) and corneal resistance factor (CRF), and signs and symptoms were collected at the one-month follow-up visit. Indicators of the level of satisfaction and quality of life after commencing treatment were determined via a satisfaction questionnaire and the NEI-RQL-42 questionnaire.
Results: Baseline data from 26 CCF and 24 ICF participants were analysed and no significant differences were observed between the two groups (p > 0.05). The first fit success rates were 90 % for CCF group and 83 % for the ICF group, SER reductions were 97 % and 95 % for the CCF and ICF group, respectively, with uncorrected high-contrast visual acuity of -0.06 (-0.18 to 0.42) and 0.00 (-0.16 to 0.52), respectively (p > 0.05) at the 1-month visit. Overall, the incidence of corneal staining was 77 % in the CCF and 79 % in ICF group; central corneal staining was 15 % and 33 %, respectively. However, the differences of corneal staining between the groups did not reach significance in any visit (p > 0.05). The main complaint from participants was glare (both groups). No significant differences in CRF and CH were found in the first month (p > 0.05). Both groups recorded high scores in the level of satisfaction questionnaire, with no significant differences between groups (p > 0.05). Compared with baseline scores, 1-month NEI-RQL-42 subscales of dependence on correction, appearance, and satisfaction with correction significantly increased, and the glare score significantly decreased in both groups (all p < 0.05).
Conclusions: The majority of participants were satisfied with the treatment and no serious corneal adverse effects were observed. These results demonstrate that ortho-k lenses of default and increased compression factor (1D) demonstrated similar clinical performance and ortho-k can be a safe and well-accepted option for myopia correction in adults, but long-term observation is warranted.
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