A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
NCT ID: NCT02643342
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2016-06-18
2019-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Single-vision glasses
Subjects wearing single-vision glasses CR-39 of refractive index 1.56.
No interventions assigned to this group
Orthokeratology with normal compression factor
Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D.
Orthokeratology
Orthokeratology with increased compression factor
Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.
Orthokeratology
Interventions
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Orthokeratology
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
10 Years
ALL
Yes
Sponsors
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Menicon Co., Ltd.
INDUSTRY
Queensland University of Technology
OTHER
Aston University
OTHER
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Pauline Cho
Professor
Principal Investigators
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Pauline Cho, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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School of Optometry, The Hong KOng Polytechnic University
Hong Kong, , China
Countries
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References
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Lam CS, Lam CH, Cheng SC, Chan LY. Prevalence of myopia among Hong Kong Chinese schoolchildren: changes over two decades. Ophthalmic Physiol Opt. 2012 Jan;32(1):17-24. doi: 10.1111/j.1475-1313.2011.00886.x.
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.
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.
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.
Gonzalez-Meijome JM, Villa-Collar C, Queiros A, Jorge J, Parafita MA. Pilot study on the influence of corneal biomechanical properties over the short term in response to corneal refractive therapy for myopia. Cornea. 2008 May;27(4):421-6. doi: 10.1097/ICO.0b013e318164e49d.
Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with keratoconus. Cornea. 2012 Aug;31(8):849-54. doi: 10.1097/ICO.0b013e318243e42d.
Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.
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.
Wan K, Lau JK, Cheung SW, Cho P. Orthokeratology with increased compression factor (OKIC): study design and preliminary results. BMJ Open Ophthalmol. 2020 May 4;5(1):e000345. doi: 10.1136/bmjophth-2019-000345. eCollection 2020.
Other Identifiers
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HSEARS20150909002
Identifier Type: -
Identifier Source: org_study_id
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