Effect of Peripheral Defocus on Axial Eye Growth and Modulation of Refractive Error in Hyperopes: Protocol for a Nonrandomized Clinical Trial.

BACKGROUND: Hyperopia occurs due to insufficient ocular growth and a failure to emmetropize in childhood. In anisohyperopia, it is unclear why one eye may remain hyperopic while the fellow eye grows toward an emmetropic state. Animal studies have shown that manipulating peripheral defocus through optical means while simultaneously providing correct axial focus can either discourage or encourage axial eye growth to effectively treat myopia or hyperopia, respectively. Myopia progression and axial eye growth can be significantly reduced in children and adolescents through the use of multifocal contact lenses. These contact lenses correct distance central myopia while simultaneously imposing relative peripheral myopic defocus. The effect of correcting distance central hyperopia while simultaneously imposing relative peripheral hyperopic defocus is yet to be elucidated in humans.

OBJECTIVE: The objective of our study is to understand the natural progression of axial eye growth and refractive error in hyperopes and anisohyperopes and to establish whether axial eye growth and refractive error can be modified using multifocal contact lenses in hyperopes and anisohyperopes.

METHODS: There are 3 elements to the program of research. First, the natural progression of axial eye growth and refractive error will be measured in spectacle-wearing hyperopic and anisohyperopic subjects aged between 5 and <20 years. In other words, the natural growth of the eye will be followed without any intervention. Second, as a paired-eye control study, anisohyperopes aged between 8 and <16 years will be fitted with a center-near multifocal design contact lens in their more hyperopic eye and a single-vision contact lens in the fellow eye if required. The progression of axial eye growth and refractive error will be measured and compared. Third, subjects aged between 8 and <16 years with similar levels of hyperopia in each eye will be fitted with center-near multifocal design contact lenses in each eye; the progression of axial eye growth and refractive error in these subjects will be measured and compared with those of subjects in the natural progression study.

RESULTS: Recruitment commenced on 6 June 2016 and was completed on 8 April 2017. We estimate the data collection to be completed by April 2020.

CONCLUSIONS: This trial will establish whether axial eye growth can be accelerated in children with hyperopia by imposing relative peripheral hyperopic defocus using center-near multifocal contact lenses.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02686879; https://clinicaltrials.gov/ct2/show/NCT02686879 (Archived by Webcite at https://www.webcitation.org/71o5p3fD2).

REGISTERED REPORT IDENTIFIER: RR1-10.2196/9320.