Combined Atropine With Orthokeratology in Childhood Myopia Control (AOK) -A Randomized Controlled Trial

NCT02955927 | Completed DMC

• 1 other identifier: HSEARS20160406005/UW 16-404
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare effects in retardation of myopia progression of combined ortho-k and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus on optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect. Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic progression.The use of 1% atropine was limited by the manifestation of side effects and rebound effect.However, both side effect and rebound effect was minimal with 0.01% atropine.It was suggested that 0.01% was 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.It is possible that by combining these two methods, additional retardation of myopia progression could be achieved.

Conditions

Myopia

Keywords

Myopia control,ortho-k, atropine eye drops, children

Outcome Measures

Primary Outcomes (1)

• Changes in axial length in 2 years

  Every 6 months for a period of 2 years

Study Arms (2)

ortho-k and 0.01% atropine eye drops

EXPERIMENTAL

participants will receive treatment of ortho-k and 0.01% atropine eye drops

Drug: 0.01% atropine eye drops; Device: ortho-k

ortho-k

ACTIVE COMPARATOR

participants will receive treatment of ortho-k alone

Device: ortho-k

Interventions

0.01% atropine eye drops DRUG

ortho-k and 0.01% atropine eye drops

ortho-k DEVICE

ortho-k; ortho-k and 0.01% atropine eye drops

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Related Publications (17)

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  PMID: 22150586 BACKGROUND

• 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.

  PMID: 22150587 BACKGROUND

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  PMID: 21105971 BACKGROUND

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  PMID: 22559900 BACKGROUND

• 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.

  PMID: 22205604 BACKGROUND

• 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.

  PMID: 21282579 BACKGROUND

• 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.

  PMID: 26605331 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.

  PMID: 15875367 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.

  PMID: 22969068 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.

  PMID: 24003088 BACKGROUND

• 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.

  PMID: 16996612 BACKGROUND

• 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.

  PMID: 21963266 BACKGROUND

• 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.

  PMID: 26271839 BACKGROUND

• 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.

  PMID: 6514306 BACKGROUND

• 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.

  PMID: 22761258 BACKGROUND

• 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.

  PMID: 22836762 BACKGROUND

• 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.

  PMID: 32776533 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Pauline Pauline, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: November 1, 2016
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

HK (1)