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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UNKNOWN
NA
66 participants
INTERVENTIONAL
2018-08-04
2024-01-31
Brief Summary
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Detailed Description
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Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ortho-k lenses and thinner spectacles
participants using conventionally designed ortho-k lenses (target for 4.00D) and thinner spectacles during day time
ortho-k lenses and thinner spectacles
Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time
newly designed ortho-k lenses
participants using newly designed ortho-k lenses for high myopia (target for full correction)
newly designed ortho-k lenses
Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)
Interventions
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ortho-k lenses and thinner spectacles
Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time
newly designed ortho-k lenses
Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)
Eligibility Criteria
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Inclusion Criteria
* Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes
* Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter.
* Best-corrected Monocular Snellen visual acuity 6/7.5 or better
Exclusion Criteria
* Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles)
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
* Previous history of ocular surgery, trauma, or chronic ocular disease
* Concurrent use of medications that may affect tear quality or contact lens wear
* Systemic or ocular conditions that may affect tear quality or contact lens wear (e.g allergy and concurrent medication) or that may affect refractive development (e.g Down syndrome, ptosis)
* Poor compliance to tests (e.g poor fixation in noncontact tonometry or intolerance of lens wear)
* Not willing to comply with the allocated treatment, use and care of lenses and follow-up schedule
7 Years
13 Years
ALL
Yes
Sponsors
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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
Kowloon, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Lam CS, Goldschmidt E, Edwards MH. Prevalence of myopia in local and international schools in Hong Kong. Optom Vis Sci. 2004 May;81(5):317-22. doi: 10.1097/01.opx.0000134905.98403.18.
Walline JJ, Lindsley K, Vedula SS, Cotter SA, Mutti DO, Twelker JD. Interventions to slow progression of myopia in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD004916. doi: 10.1002/14651858.CD004916.pub3.
Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
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.
Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. doi: 10.1111/j.1444-0938.2006.00044.x.
Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J Ophthalmol. 2009 Sep;93(9):1181-5. doi: 10.1136/bjo.2008.151365. Epub 2009 May 4.
Charm J, Cho P. High myopia-partial reduction orthokeratology (HM-PRO): study design. Cont Lens Anterior Eye. 2013 Aug;36(4):164-70. doi: 10.1016/j.clae.2013.02.012. Epub 2013 Mar 18.
Cho P, Cheung SW, Edwards MH. Practice of orthokeratology by a group of contact lens practitioners in Hong Kong. Part 2: orthokeratology lenses. Clin Exp Optom. 2003 Jan;86(1):42-6. doi: 10.1111/j.1444-0938.2003.tb03056.x.
Lee TT, Cho P. Relative peripheral refraction in children: twelve-month changes in eyes with different ametropias. Ophthalmic Physiol Opt. 2013 May;33(3):283-93. doi: 10.1111/opo.12057.
Atchison DA, Li SM, Li H, Li SY, Liu LR, Kang MT, Meng B, Sun YY, Zhan SY, Mitchell P, Wang N. Relative Peripheral Hyperopia Does Not Predict Development and Progression of Myopia in Children. Invest Ophthalmol Vis Sci. 2015 Sep 1;56(10):6162-70. doi: 10.1167/iovs.15-17200.
Hiraoka T, Matsumoto Y, Okamoto F, Yamaguchi T, Hirohara Y, Mihashi T, Oshika T. Corneal higher-order aberrations induced by overnight orthokeratology. Am J Ophthalmol. 2005 Mar;139(3):429-36. doi: 10.1016/j.ajo.2004.10.006.
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.
Other Identifiers
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HSEARS20180322002
Identifier Type: -
Identifier Source: org_study_id
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