Investigation of the Effect of Short-term Orthokeratology With Increased Compression Factor on Ocular Parameters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Changes in Spherical Equivalent Refraction
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •6 to 10 years old
- •Myopia: between 0.50 D and 4.00 D in both eyes
- •Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- •Anisometropia: ≤ 1.50 D
- •Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
- •Agree for randomization
Exclusion Criteria
- •Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- •Any type of strabismus or amblyopia
- •Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- •Rigid contact lenses (including orthokeratology lenses) experience
- •Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- •Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
- •Poor compliance for lens wear or follow-up
Arms & Interventions
Ortho-k lens with normal compression factor
The eye wears ortho-k lens with normal compression factor to achieve plano (+/- 0.25D) correction.
Intervention: Orthokeratology (Device)
Ortho-k lenses with increased compression factor
The eye wears ortho-k lenses with increased compression factor to achieve 1 diopter (+/- 0.25D) over correction.
Intervention: Orthokeratology (Device)
Outcomes
Primary Outcomes
Changes in Spherical Equivalent Refraction
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.
Secondary Outcomes
- Changes in Subfoveal Choroidal Thickness(baseline and one month)
- Changes in Higher Order Aberrations(baseline and one month)
Investigators
Pauline Cho
Professor
The Hong Kong Polytechnic University
