None listed
Conditions
Brief summary
Myopia (short sightedness) is a refractive condition where the distance from the front to the back of the eye is too long for the refractive strength of the eye, leading to light being focussed in front of the retina (light sensitive layer on the inside back of the eye) and subsequently causing blurred vision. Myopia typically develops in childhood while the eye is growing and is believed to be accelerated by correcting the myopia with glasses. When myopia first presents the child complains of poor distance vision which is corrected by glasses. Unfortunately, myopia continues to progress requiring the child to return at regular intervals to get ever stronger glasses, until they reach adulthood. Orthokeratology (OK) lenses are specialised contact lenses that are worn during sleep to reshape the front surface of the eye to temporarily correct myopia. Recent research has shown that OK lenses are effective at slowing progression of myopia by 50%. These encouraging results have led contact lens manufacturers to develop OK lens designs with greater effectivity in slowing progression of myopia. While these ‘Myopia Control’ OK lenses are now being supplied to optometry practices and marketed as being more effective in slowing progression of myopia compared to standard OK lens designs, there is no scientific evidence to support that they are any more effective than standard OK designs. The aim of this project is to increase understanding on how myopia control OK lens designs will affect known stimuluses for myopia progression compared to standard OK lens designs. The scientific literature reveals that OK causes peripheral light rays to be focussed further towards the front of the eye than central light rays, which is termed peripheral myopic defocus. Peripheral myopic defocus has been shown to slow progression of myopia in animal models, and this same mechanism is believed to be the reason why OK lenses slow progression of myopia. The manufacturers of myopia control OK lens designs claim that they are more effective at slowing progression of myopia compared to standard OK lens designs because they create a greater amount of peripheral myopic defocus. We are going to investigate the potential for greater slowing of myopia progression with myopia control OK lens designs, by measuring the effect that the different OK designs have on myopic defocus in young adults over 1 week of wear, which is the reported shortest duration of time for the full refractive effect to be achieved. This study is important as optometrists need to know the true effect that OK lenses marketed to slow myopia progression have on refractive mechanisms that have been shown to retard progression of myopia, if they are to be effective in managing myopia in their child patients. Outcomes will also assist the design of future longitudinal studies using standard and myopia control OK lens designs.
Interventions
Two different orthokeratology lens designs are to be worn in randomised order for a period of 1 week overnight wear each, after which purposely induced changes to corneal shape and associated effect on refraction profile will be measured and compared, with a minimum 1 week duration washout period between the two iterations where no lenses will be worn. Each iteration will be worn overnight only in both eyes for a minimum of 5 hours and maximum of 12 hours.The orthokeratology lenses will be fitted by university researchers under the direct supervision of qualified University of New South Wales (UNSW), Sydney, employed optometrists. Participants will be required to self insert the lenses at their home before sleep and remove them on waking, with all training and support on how to insert and remove lenses and deal with any lens adherence provided. After each week of overnight wear participants will be required to return to UNSW for study measurements. Participants will be required to attend the study centre after the first night of lens wear to assess lens fit and to ensure that participants are successful in removing the lenses and in taking the correct cleaning and storage steps unguided. Participants will not be allowed to continue with the study until they are competent at removing and caring for the lenses without guidance. In the unlikely case that a participant has found the lens to be bound and can't be loosened with the resolution steps provided they will be instructed to contact the investigators for advice.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Healthy individuals aged between 18-40 2. Have short-sightedness (myopia) between -1.ooD and -4.ooD and less than -1.50D of corneal astigmatism 3. No previous rigid contact lens wear 4. Have good ocular health and general health 5. No contraindications to rigid contact lens wear
Exclusion criteria
1. Strabismus or amblyopia 2. Systemic or ocular conditions that may affect tear quality or contact lens wear or that may affect refractive development 3. Previous history or ocular surgery, trauma, or chronic ocular disease 4. Ocular or systemic medication use that may interfere with contact lens wear or ocular surface 5. Not willing to comply with the allocated treatment and follow-up scheduole