This study adhered to the tenets of the Declaration of Helsinki. The Queensland University of Technology Human Research Ethics Committee approved the protocol. All participants signed the informed consent form before enrolment into the study. A double-masked two-arm parallel randomized controlled trial was conducted over 12 months of follow-up at the School of Optometry and Vision Science. This trial was registered with the Australian New Zealand Clinical Trials Registry (Reg. No. ACTRN12619000538145).
Fifty-two myopes aged between 18 and 27 years were recruited from Queensland University of Technology students and their acquaintances. They were the myopic participants of the Kaphle et al. (2022) (link) study. Young adults have been used in preference to children because of the difficulties of maintaining attention of children during the lengthy and tedious measurement process. They had non-cycloplegic SER between −0.75 D and −6.00 D. All participants had good ocular and general health, anisometropia and cylinders < 1.75 D, and no past or current history of myopia control treatment. Participants were allocated randomly one of two PAL designs, both of which had an addition power of 1.50 D at the near reference point (NRP).
A questionnaire was administered at each visit to assess compliance of new spectacles. If there were any issues with adaptation, they were resolved by troubleshooting. Compliance issues, if any, were recorded. The proportion for participants wearing spectacles at least 12 hours or more ranged from 90% to 95% for all follow-up visits. There was no significant difference between the two designs regarding compliance or number of hours of wear.
Figure 1 shows the flow chart of the 12-month trial. The trial was affected by the COVID-19 pandemic, which contributed to a considerable amount of missing data when participants could not return for scheduled visits.
Fifty-two myopes aged between 18 and 27 years were recruited from Queensland University of Technology students and their acquaintances. They were the myopic participants of the Kaphle et al. (2022) (link) study. Young adults have been used in preference to children because of the difficulties of maintaining attention of children during the lengthy and tedious measurement process. They had non-cycloplegic SER between −0.75 D and −6.00 D. All participants had good ocular and general health, anisometropia and cylinders < 1.75 D, and no past or current history of myopia control treatment. Participants were allocated randomly one of two PAL designs, both of which had an addition power of 1.50 D at the near reference point (NRP).
A questionnaire was administered at each visit to assess compliance of new spectacles. If there were any issues with adaptation, they were resolved by troubleshooting. Compliance issues, if any, were recorded. The proportion for participants wearing spectacles at least 12 hours or more ranged from 90% to 95% for all follow-up visits. There was no significant difference between the two designs regarding compliance or number of hours of wear.
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