- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955927
Combined Atropine With Orthokeratology in Childhood Myopia Control (AOK) -A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although it is believed that myopia is the result of an interplay between genetic and environmental factors and its progression has been attributed to the lack of outdoor activities and intensive school work, myopia control methods mainly focus on optical and pharmaceutical interventions. Use of bifocal and multifocal lenses have been shown to be ineffective in myopia control. Specially designed soft contact lenses for myopia control have recently been launched, but their effectiveness has yet to be confirmed. Currently, overnight-wear orthokeratology (ortho-k), which involves reshaping the cornea by overnight wear allowing for improved, frequently unaided, vision during the day, is used extensively in Hong Kong. Approximately 50% retardation in axial length elongation was observed in studies of patients receiving ortho-k (LORIC study, 46%, ROMIO study,43%, and TO-SEE study, 52%).
Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic progression. The use of 1% atropine was first suggested in the 1990's, but its application was limited by the manifestation of side effects such as pupil dilatation and loss of accommodation. The effectiveness of lower concentrations (0.5%, 0.1% and 0.01%) have been evaluated in a recent five-year randomized clinical trial, where the authors reported that 0.01% atropine once daily was effective resulting in about 50% of spherical equivalent reduction. However, this was as a result of one year (3rd year) discontinuation of atropine in the five-year study. Rebound effect was minimal with 0.01% atropine and higher dosages were associated with more manifest rebound effects, which appeared to negate former myopia retardation effects. Only 24% of those receiving 0.01% progressed 0.50D or more after discontinuation for one year. By contrast, proportion of children progressed 0.50D or more in 0.5% and 0.1% groups were 59% and 68% respectively. Moreover, use of 0.01% atropine showed sustained myopia reduction with clinically negligible effects on pupil dilatation and loss of accommodation. The authors suggested the use of 0.01% as the optimum concentration for controlling myopia.
The mechanisms of neither ortho-k nor atropine in myopia control are fully understood. It is believed that ortho-k and atropine act via different mechanisms, with ortho-k slowing myopia progression by reducing peripheral hyperopic defocus, while atropine exerts effects on anti-muscarinic receptors of the retina and sclera. However, some subjects respond poorly to either atropine or ortho-k, as demonstrated in clinical trials, suggesting that a single treatment may be not enough. It is possible that by combining these two methods, additional retardation of myopia progression could be achieved. In this randomized trial, we will explore the effectiveness of combination of ortho-k and atropine therapy, and evaluate additional effects by comparing the combination with ortho-k treatment alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kowloon, Hong Kong
- School of Optometry, The Hong Kong Polytechnic University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Manifest myopia between 1.00-4.00D in both eyes at screening visit
- Manifest astigmatism ≤2.50D; with-the-rule astigmatism (axes 180 ± 30) ≤2.50D; astigmatism with other axes ≤0.50D in both eyes at screening visit
- <1.00D difference in manifest spherical equivalent (SE) between the two eyes at screening visit
- Baseline cycloplegic objective refraction between 1.00-4.00D in sphere; astigmatism ≤2.50D; <1.00D difference in manifest SE between the two eyes
- Best-corrected logMAR visual acuity 0.10 or better in both eyes
- Symmetrical corneal topography with corneal toricity <2.00D in either eye
- Normal ocular health other than myopia
- Agree to be randomized and to attend the scheduled visits and aftercare
Exclusion Criteria:
- Contraindications to atropine: known allergies or cardiovascular disease, epilepsy
- Contraindications to contact lens wear and ortho-k: corneal scar, history of ocular inflammation/infection, limbus-to-limbus corneal cylinder and dislocated corneal apex
- Strabismus or amblyopia
- History of myopia control treatment (e.g. soft contact lenses, progressive add spectacles, atropine eye drops)
- Rigid contact lens (including ortho-k) wear experience
- Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- Ocular conditions which might affect refractive error (for example, cataract, ptosis)
- Poor response to lens wear including poor lens handling, poor vision and/ocular response after lens modifications
- Poor compliance with schedule visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ortho-k and 0.01% atropine eye drops
participants will receive treatment of ortho-k and 0.01% atropine eye drops
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Active Comparator: ortho-k
participants will receive treatment of ortho-k alone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Changes in axial length in 2 years
Time Frame: Every 6 months for a period of 2 years
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Every 6 months for a period of 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pauline Pauline, PhD, The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
- 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.
- Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
- Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk factors for myopia. Ophthalmic Physiol Opt. 2012 Jan;32(1):3-16. doi: 10.1111/j.1475-1313.2011.00884.x.
- 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.
- Fan DS, Lai C, Lau HH, Cheung EY, Lam DS. Change in vision disorders among Hong Kong preschoolers in 10 years. Clin Exp Ophthalmol. 2011 Jul;39(5):398-403. doi: 10.1111/j.1442-9071.2010.02470.x. Epub 2011 Feb 1.
- Berntsen DA, Sinnott LT, Mutti DO, Zadnik K. A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation. Invest Ophthalmol Vis Sci. 2012 Feb 13;53(2):640-9. doi: 10.1167/iovs.11-7769. Print 2012 Feb.
- Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group. Progressive-addition lenses versus single-vision lenses for slowing progression of myopia in children with high accommodative lag and near esophoria. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2749-57. doi: 10.1167/iovs.10-6631.
- Paune J, Morales H, Armengol J, Quevedo L, Faria-Ribeiro M, Gonzalez-Meijome JM. Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial. Biomed Res Int. 2015;2015:507572. doi: 10.1155/2015/507572. Epub 2015 Oct 28.
- 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.
- Chua WH, Balakrishnan V, Chan YH, Tong L, Ling Y, Quah BL, Tan D. Atropine for the treatment of childhood myopia. Ophthalmology. 2006 Dec;113(12):2285-91. doi: 10.1016/j.ophtha.2006.05.062. Epub 2006 Sep 25.
- Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
- Brodstein RS, Brodstein DE, Olson RJ, Hunt SC, Williams RR. The treatment of myopia with atropine and bifocals. A long-term prospective study. Ophthalmology. 1984 Nov;91(11):1373-9. doi: 10.1016/s0161-6420(84)34138-0.
- Liu Y, Wildsoet C. The effective add inherent in 2-zone negative lenses inhibits eye growth in myopic young chicks. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5085-93. doi: 10.1167/iovs.12-9628.
- Arumugam B, McBrien NA. Muscarinic antagonist control of myopia: evidence for M4 and M1 receptor-based pathways in the inhibition of experimentally-induced axial myopia in the tree shrew. Invest Ophthalmol Vis Sci. 2012 Aug 24;53(9):5827-37. doi: 10.1167/iovs.12-9943.
- Tan Q, Ng AL, Choy BN, Cheng GP, Woo VC, Cho P. One-year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial. Ophthalmic Physiol Opt. 2020 Sep;40(5):557-566. doi: 10.1111/opo.12722. Epub 2020 Aug 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Refractive Errors
- Myopia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Pharmaceutical Solutions
- Mydriatics
- Ophthalmic Solutions
- Atropine
Other Study ID Numbers
- HSEARS20160406005/UW 16-404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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