The Hong Kong Polytechnic University
Hong Kong, China
NCT Number: NCT02643875
Orthokeratology (ortho-k) is a clinical technique that uses reverse geometry rigid gas permeable contact lens exerting positive pressure on the central cornea to temporary reduce refractive error. Researchers have shown that this treatment is effective for myopia control in low to high myopes, with and without astigmatism. Most designs of ortho-k lenses in the market are fitted based on the Jessen formula. The compression factor was introduced to compensate for the regression of the ortho-k effect during the no lens-wear period, so that the wearer can obtain clear distance vision throughout the day and most lens designs use a compression factor of 0.50-0.75 D. However, in a retrospective study (mixed brands of ortho-k lenses), it showed that most patients did not achieve an over-correction of 0.75 D. In order to achieve an over-correction of 0.75 D, an extra flattening power of about 1.50 D instead of 0.75 D should be be targeted. The increased compression factor is expected to increase the target reduction and it may play a role in myopic control and providing a higher successful rate in fitting ortho-k lenses.
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Notify Me6 year–10 year
All sexes
Interventional
Not applicable
Hong Kong, China
Subjects were fitted with ortho-k lenses of conventional (0.75 D) and increased (1.75 D) compression factor. The laterality of the compression factor for each subject was randomised.
Subjects were instructed and trained with proper lens handling and disinfection procedures. Lenses were given to the subjects only when they demonstrated proper techniques.
All subjects were required to attend regular follow-ups (baseline, first overnight, and weekly over one-month period). The follow-ups were scheduled (except for the first overnight which was scheduled in the early morning) at a similar time to the baseline visit (+/- 2 hours) to minimise any potential influence of diurnal variation on ocular biometrics.
Additional unscheduled visits were provided when necessary to ensure good ocular health and vision throughout the study period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a kind of rigid permeable lens.
Time frame: baseline and one month
Maximum plus for maximum visual acuity was used as the criterion for subjective refraction.
Spherical equivalent refraction was calculated by adding the sum of the sphere power with half of the cylinder power.
Time frame: baseline and one month
The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface.
Time frame: baseline and one month
Ocular higher order aberrations were measured using Shack-Hartmann aberrometer. The wavefront data was fitted with a sixth order Zernike polynomial over a 5-mm pupil size.
The Hong Kong Polytechnic University
Other
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