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| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
| Queensland University of Technology | OTHER |
| Aston University | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-k lens with normal compression factor | Sham Comparator | The eye wears ortho-k lens with normal compression factor to achieve plano (+/- 0.25D) correction. |
|
| Ortho-k lenses with increased compression factor | Active Comparator | The eye wears ortho-k lenses with increased compression factor to achieve 1 diopter (+/- 0.25D) over correction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthokeratology | Device | It is a kind of rigid permeable lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Spherical Equivalent Refraction | 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. | baseline and one month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Subfoveal Choroidal Thickness | The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface. | baseline and one month |
| Changes in Higher Order Aberrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pauline Cho, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15875367 | Background | Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children (LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr Eye Res. 2005 Jan;30(1):71-80. doi: 10.1080/02713680590907256. | |
| 22969068 | Background | Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012 Oct 11;53(11):7077-85. doi: 10.1167/iovs.12-10565. |
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All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigned to the treatment for each eye according to the randomization log.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthokeratology Lenses With Different Compression Factors | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data of subjects who completed the study were reported
| ID | Title | Description |
|---|---|---|
| BG000 | Orthokeratology Lenses With Different Compression Factors | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Spherical Equivalent Refraction | 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. | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. | Posted | Mean | Standard Deviation | D | baseline and one month | eyes | eyes |
|
one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Compression Factor (0.75 D) | Orthokeratology lenses with conventional compression factor (0.75 D) were randomly assigned to one eye of each subject. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Pauline Cho | The Hong Kong Polytechnic University | (852) 2766-6100 | sopaulin@polyu.edu.hk |
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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. |
| baseline and one month |
| 24003088 | Background | Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527. |
| 18426426 | Background | Chan B, Cho P, Mountford J. The validity of the Jessen formula in overnight orthokeratology: a retrospective study. Ophthalmic Physiol Opt. 2008 May;28(3):265-8. doi: 10.1111/j.1475-1313.2008.00545.x. |
| 31704093 | Result | Wan K, Lau JK, Cheung SW, Cho P. Refractive and corneal responses of young myopic children to short-term orthokeratology treatment with different compression factors. Cont Lens Anterior Eye. 2020 Feb;43(1):65-72. doi: 10.1016/j.clae.2019.10.134. Epub 2019 Nov 6. |
| 31264269 | Result | Lau JK, Vincent SJ, Cheung SW, Cho P. The influence of orthokeratology compression factor on ocular higher-order aberrations. Clin Exp Optom. 2020 Jan;103(1):123-128. doi: 10.1111/cxo.12933. Epub 2019 Jul 1. |
| 31360614 | Result | Lau JK, Wan K, Cheung SW, Vincent SJ, Cho P. Weekly Changes in Axial Length and Choroidal Thickness in Children During and Following Orthokeratology Treatment With Different Compression Factors. Transl Vis Sci Technol. 2019 Jul 23;8(4):9. doi: 10.1167/tvst.8.4.9. eCollection 2019 Jul. |
| eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Spherical equivalent refraction | 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. | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. | Mean | Standard Deviation | D | eyes |
|
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| Units | Counts |
|---|
| Participants |
|
| eyes |
|
|
| Secondary | Changes in Subfoveal Choroidal Thickness | The subfoveal choroidal thickness was determined as the thickness between the outer retinal pigment epithelium/Bruch's membrane complex and the inner chorioscleral interface. | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. | Posted | Mean | Standard Deviation | um | baseline and one month | eyes | eyes |
|
|
|
| Secondary | Changes in Higher Order Aberrations | 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. | Orthokeratology lenses with different compression factors (one eye with 0.75 D and the fellow eye with 1.75 D) were randomly assigned to each subject. | Posted | Mean | Standard Error | um | baseline and one month | eyes | eyes |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Increased Compression Factor (1.75 D) | Orthokeratology lenses with increased compression factor (1.75 D) were randomly assigned to the fellow eye of each subject. | 0 | 28 | 0 | 28 | 0 | 28 |
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| Increased compression factor (1.75 D) |
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| Increased compression factor (1.75 D) |
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