The future of corneal refractive reshaping: can we control myopia or is the risk of corneal compromise too great?

A prospective, randomised, controlled, cross-over study to evaluate the effects of orthokeratology versus conventional rigid gas permeable contact lens wear on the progression of myopia in children and adolescents.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000007336

Enrollment

Registered

2008-01-09

Start date

2008-01-23

Completion date

2009-04-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether the use of overnight orthokeratology contact lenses slows the progression of eye growth in myopic children and adolescents compared to conventional rigid contact lens wear and spectacle use. At the same time the relative risk for corneal infection (microbial keratitis) with overnight orthokeratology will be evaluated indirectly, using a well-established technique that analyses corneal cell shedding rates and bacterial attachment to these harvested corneal cells. The relationship between myopia progression and peripheral refractive status will also be investigated.

Interventions

Subjects with progressing myopia will wear an orthokeratology lens (BE design; RD1800 material) in one eye on an overnight basis, and a conventional rigid gas-permeable (RGP) contact lens (J-Contour design, RD1800 material) in the other eye for either daily or extended wear, for a 6-month period. After 6 months, the eye/lens combinations will be reversed and the lenses worn for a further 6 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

8 Years to 16 Years

Healthy volunteers

Yes

Inclusion criteria

Participants will be required to have myopic refractive error between -1.00 and -4.00D at the time of study enrolment, evidence of progression of myopia over the previous 12 months, <0.75D refractive difference between the two eyes, <1.50D with-the-rule corneal astigmatism, and no against-the-rule astigmatism. Subjects must be of East Asian ethnicity, have good general and ocular health, and no history of rigid contact lens wear. Normal corneal topography, normal binocular function, and vision correctable to 6/9 (20/30) or better are also required for study enrolment.

Exclusion criteria

Potential subjects will not be enrolled if they show any contraindications for rigid contact lens wear, abnormal binocular function, anisometropia > 0.75D, ocular pathology or active ocular surface disease that would preclude contact lens wear.

Outcome results