Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

NCT01236742 | Completed Results

• 1 other identifier: H-ZG50-1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.

Conditions

Myopia

Keywords

children; corneal reshaping; myopia; myopia progression; orthokeratology

Outcome Measures

Primary Outcomes (1)

• Change in Axial Length

  To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects

  Baseline, 7 months, and 14 months after baseline

Secondary Outcomes (1)

• Incidence of Adverse Effects

  14 months

Study Arms (3)

single-vision glasses and ortho-k lenses

EXPERIMENTAL

Children who are currently wearing ortho-k lenses at night for correction of refractive errors will be switched to wear single-vision glasses for the first 7 months and then switched back to ortho-k lenses for the next 7 months

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

ortho-k lenses

ACTIVE COMPARATOR

Children who are currently wearing ortho-k lenses at night for the correction of refractive errors will continue with the current treatment and serve as the first control group

Device: ortho-k lenses

single-vision glasses

OTHER

Children who are currently wearing single-vision spectacles in the daytime for correcting their refractive errors will continue with the current treatment and serve as the second control group

Device: single-vision glasses

Interventions

ortho-k lenses DEVICE

nightly wear of orthokeratology lenses to correct vision

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

ortho-k lenses; single-vision glasses and ortho-k lenses

single-vision glasses DEVICE

daily wear of spectacle glasses to correct vision

Also known as: CR-39 lenses

single-vision glasses; single-vision glasses and ortho-k lenses

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-14 years old (inclusive)
• Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
• Willingness to be randomized into groups (for ortho-k subjects)
• Availability for follow-up for at least 14 months

You may not qualify if:

• Non-compliance to the follow up schedule
• Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
• 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)

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 (4)

• 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

• 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

• Cho P, Cheung SW. Discontinuation of orthokeratology on eyeball elongation (DOEE). Cont Lens Anterior Eye. 2017 Apr;40(2):82-87. doi: 10.1016/j.clae.2016.12.002. Epub 2016 Dec 27.

  PMID: 28038841 RESULT

• Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

  PMID: 36809645 DERIVED

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 18, 2017
• Results First Posted: November 8, 2017

Record last verified: 2017-11

Locations

CN (1)