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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

single-vision glasses

ortho-k lenses

About this trial

This is an interventional treatment trial for Myopia focused on measuring children, corneal reshaping, myopia, myopia progression, orthokeratology

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

School of Optometry, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ortho-k lenses

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Serious Adverse Effects

Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva

Full Information

NCT ID

NCT01236755

First Posted

November 8, 2010

Last Updated

February 29, 2020

Sponsor

The Hong Kong Polytechnic University

Collaborators

Menicon Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01236755

Brief Title

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

Acronym

DOEE2

Official Title

Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

Collaborators

Menicon Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Younger myopic children (aged 6-10 years old) may have the faster increase in myopia than old myopic children (aged 11-15 years old), i.e. the rate of myopic progression may be different in different age groups and in children with different refractive status (Edwards 1999; Fan et al. 2004; Cheng et al. 2007). Although the refractive correction with ortho-k has been well documented, it is unknown whether the efficiency and reversibility of ortho-k for myopic reduction as well as myopic control are similar in children of different age and refractive groups. In this 14-month study, the eyeball length in 45 younger (6-10 years old) and 45 older (11-15 years old) myopic children before and after ortho-k will be evaluated. Eyeball elongation will be determined for the first 7 months when single-vision glasses will be prescribed (Phase I) and the next 7 months when ortho-k will be prescribed (Phase I). Rate of myopic progression will be determined and compared between the two groups of children in the two phases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

children, corneal reshaping, myopia, myopia progression, orthokeratology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

Single

Masking Description

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

Allocation

N/A

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ortho-k lenses

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

single-vision glasses

Other Intervention Name(s)

CR-39 lenses

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

ortho-k lenses

Other Intervention Name(s)

orthokeratology, corneal reshaping therapy, Menicon Z Night lenses, Menicon Z Night Toric lenses

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Axial Elongation in the Two Study Phases

Description

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

Time Frame

14 months

Secondary Outcome Measure Information:

Title

Number of Participants With Serious Adverse Effects

Description

Number of subjects with serious adverse effects of the cornea, the palpebral, bulbar and tarsal conjunctiva

Time Frame

14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pauline Cho, PhD

Organizational Affiliation

The Hong Kong Polytechnic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Optometry, The Hong Kong Polytechnic University

City

Hong Kong

State/Province

Hong Kong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

17220775

Citation

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.

Results Reference

background

PubMed Identifier

15875367

Citation

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.

Results Reference

background

PubMed Identifier

10645384

Citation

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.

Results Reference

background

PubMed Identifier

15037570

Citation

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.

Results Reference

background

PubMed Identifier

19416935

Citation

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.

Results Reference

background

PubMed Identifier

30366778

Citation

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.

Results Reference

result

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

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