Discontinuation of Lens Wear in New Ortho-k Children (DOEE2)

NCT01236755 | Completed Results

• 1 other identifier: H-ZG50-2
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at investigating the efficacy of myopic control using ortho-k in younger and older children.

Conditions

Myopia

Keywords

children; corneal reshaping; myopia; myopia progression; orthokeratology

Outcome Measures

Primary Outcomes (1)

• Change in Axial Elongation in the Two Study Phases

  Axial elongation in children during the two study phases. Phase I: 7 months wearing single-vision spectacles. Phase II: 7 months wearing orthokeratology

  14 months

Secondary Outcomes (1)

• Number of Participants With Serious Adverse Effects

  14 months

Study Arms (1)

ortho-k lenses

EXPERIMENTAL

Children were switched to wear ortho-k lenses for 7 months after wearing single-vision glasses for 7 months

Device: single-vision glasses; Device: ortho-k lenses

Interventions

single-vision glasses DEVICE

Daily wear of glasses to correct vision in the first seven months of the study

Also known as: CR-39 lenses

ortho-k lenses

ortho-k lenses DEVICE

Nightly wear of lenses to correct vision in day time in the second seven months of the study

Also known as: orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lenses

ortho-k lenses

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: between 6 to 15 years old
• Myopia: between 1.50D and 4.50D in at least one eye
• Spherical equivalent (SE): between -1.00D to -4.50D in both eyes
• Astigmatism: ≤ 3.00D of axes 180 +/- 30 or ≤ 1.00D of other axes; and the amount is less than refractive sphere
• Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
• Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
• Willingness to wear contact lenses or spectacles on a daily basis
• Can obtain good ortho-k results with the study lenses
• Availability for follow-up for at least 14 months

You may not qualify if:

• Strabismus at distance or near
• Contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
• Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
• Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
• Prior experience with the use of rigid lenses (including ortho-k)
• Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
• Non-compliance to the follow up schedule
• Non-compliance to the use of the prescribed optical correction
• Poor ocular response to ortho-k lens wear
• Significant residual refractive error after ortho-k treatment resulting in poor unaided vision (worse than 0.18 in logMAR scale)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Menicon Co., Ltd.: collaborator

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Location

Related Publications (6)

• Cheng D, Schmid KL, Woo GC. Myopia prevalence in Chinese-Canadian children in an optometric practice. Optom Vis Sci. 2007 Jan;84(1):21-32. doi: 10.1097/01.opx.0000254042.24803.1f.

  PMID: 17220775 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

• Edwards MH. The development of myopia in Hong Kong children between the ages of 7 and 12 years: a five-year longitudinal study. Ophthalmic Physiol Opt. 1999 Jul;19(4):286-94. doi: 10.1046/j.1475-1313.1999.00445.x.

  PMID: 10645384 BACKGROUND

• Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.

  PMID: 15037570 BACKGROUND

• 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.

  PMID: 19416935 BACKGROUND

• Cheung SW, Boost MV, Cho P. Pre-treatment observation of axial elongation for evidence-based selection of children in Hong Kong for myopia control. Cont Lens Anterior Eye. 2019 Aug;42(4):392-398. doi: 10.1016/j.clae.2018.10.006. Epub 2018 Oct 24.

  PMID: 30366778 RESULT

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Prof Pauline Cho
• Organization: The Hong Kong Polytechnic University

pauline.cho@polyu.edu.hk

+852 2766-6100

Study Officials

• Pauline Cho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Masking Details: The outcome assessor was responsible for measuring the axial length and was unaware of the intervention (i.e. spectacles or orthokeratology) used by the subjects
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All subjects were prescribed with a pair of glasses for seven months and switched to orthokeratology for another seven months

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2020
• Results First Posted: September 19, 2019

Record last verified: 2020-02

Locations

CN (1)