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

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01236755
• Collaborator: Menicon Co., Ltd. (Industry)
• Enrollment: 91
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: single-vision glasses; Device: ortho-k lenses	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects were prescribed with a pair of glasses for seven months and switched to orthokeratology for another seven monthsAll 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
• Primary Purpose: Treatment
• Official Title: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (2) Discontinuation of Lens Wear in New Ortho-k Children
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ortho-k lenses Children were switched to wear ortho-k lenses for 7 months after wearing single-vision glasses for 7 months	Device: single-vision glasses; Daily wear of glasses to correct vision in the first seven months of the study; Other Names: CR-39 lenses ; Device: ortho-k lenses; Nightly wear of lenses to correct vision in day time in the second seven months of the study; Other Names: orthokeratology corneal reshaping therapy Menicon Z Night lenses Menicon Z Night Toric lenses

Outcome Measures

Primary Outcome Measures

1. Change in Axial Elongation in the Two Study Phases [14 months]

   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

1. Number of Participants With Serious Adverse Effects [14 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry, The Hong Kong Polytechnic University	Hong Kong	Hong Kong	China

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• Menicon Co., Ltd.

Investigators

• Principal Investigator: Pauline Cho, PhD, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Pauline Cho, Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT01236755
• Other Study ID Numbers: H-ZG50-2
• First Posted: Nov 9, 2010
• Last Update Posted: Mar 11, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Pauline Cho, Professor, The Hong Kong Polytechnic University: children; corneal reshaping; myopia; myopia progression; orthokeratology
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Subjects in Spectacle and Ortho-k Wearing Phases
Arm/Group Description	Subjects enrolled in the study during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
Period Title: Spectacles Wearing Phase
STARTED	91
COMPLETED	74
NOT COMPLETED	17
Period Title: Spectacles Wearing Phase
STARTED	74
COMPLETED	66
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Subjects Completed the 14-month Study
Arm/Group Description	Subjects who have completed the study in which they used single-vision spectacles every day for 7 months in Phase I and ortho-k lenses every night for the next 7 months in Phase II to correct their vision.
Overall Participants	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.3 (2.3)
Sex: Female, Male (Count of Participants)
Female	39 59.1%
Male	27 40.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	66 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Hong Kong	66 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axial Elongation in Spectacle and Ortho-k Wearing Phases
Arm/Group Description	Axial elongation in children during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
Measure Participants	66
spectacles wearing phase	0.163 (0.121)
orthokeratology wearing phase	0.047 (0.112)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Serious Adverse Events in Spectacle and Ortho-k Wearing Phases
Arm/Group Description	Number of subjects with serious adverse events in the cornea and conjunctiva during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
Measure Participants	66
spectacles wearing phase	0 0%
orthokeratology wearing phase	0 0%

Adverse Events

Time Frame	The study started in October 2010 and ended in July 2013. Adverse events during the 33 months were collected and reported
Adverse Event Reporting Description	It was a cross-over study in which there was only one Arm/Group. Therefore, the adverse events for the single-vision and orthokeratology phases were combined. The adverse events for each intervention can be found under the second primary outcome in which the results from the two interventions were presented in the two rows
Arm/Group Title	Serious Adverse Events in Spectacle and Ortho-k Wearing Phase
Arm/Group Description	Number of subjects with serious adverse events of the cornea and conjunctiva during the first 7 months in Phase I (daily wear of single-vision spectacles) and the next 7 months in Phase II (nightly wear of orthokeratology lenses)
All Cause Mortality
	Serious Adverse Events in Spectacle and Ortho-k Wearing Phase
	Affected / at Risk (%)	# Events
Total	0/66 (0%)
Serious Adverse Events
	Serious Adverse Events in Spectacle and Ortho-k Wearing Phase
	Affected / at Risk (%)	# Events
Total	0/66 (0%)
Other (Not Including Serious) Adverse Events
	Serious Adverse Events in Spectacle and Ortho-k Wearing Phase
	Affected / at Risk (%)	# Events
Total	0/66 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.