DOEE1: Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01236742
• Collaborator: Menicon Co., Ltd. (Industry)
• Enrollment: 53
• Location: 1
• Arms: 3
• Duration (Months): 35
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: ortho-k lenses; Device: single-vision glasses	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). Both studies showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment.

Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k Children
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single-vision glasses and ortho-k lenses 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; nightly wear of orthokeratology lenses to correct vision; Other Names: orthokeratology corneal reshaping therapy Menicon Z Night lenses Menicon Z Night Toric lenses ; Device: single-vision glasses; daily wear of spectacle glasses to correct vision; Other Names: CR-39 lenses
Active Comparator: ortho-k lenses 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; nightly wear of orthokeratology lenses to correct vision; Other Names: orthokeratology corneal reshaping therapy Menicon Z Night lenses Menicon Z Night Toric lenses
Other: single-vision glasses 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; daily wear of spectacle glasses to correct vision; Other Names: CR-39 lenses

Outcome Measures

Primary Outcome Measures

1. Change in Axial Length [Baseline, 7 months, and 14 months after baseline]

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

Secondary Outcome Measures

1. Incidence of Adverse Effects [14 months]

   The observation of serious and non-serious adverse events in the 14 months of study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

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

• 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.
• 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: NCT01236742
• Other Study ID Numbers: H-ZG50-1
• First Posted: Nov 9, 2010
• Last Update Posted: Dec 18, 2017
• Last Verified: Nov 1, 2017

• 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	Single-vision Glasses and Ortho-k Lenses	Ortho-k Lenses	Single-vision Glasses
Arm/Group Description	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision	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 single-vision glasses: daily wear of spectacle glasses to correct vision
Period Title: Overall Study
STARTED	18	19	16
COMPLETED	15	16	13
NOT COMPLETED	3	3	3

Baseline Characteristics

Arm/Group Title	Single-vision Glasses and Ortho-k Lenses	Ortho-k Lenses	Single-vision Glasses	Total
Arm/Group Description	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision	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 single-vision glasses: daily wear of spectacle glasses to correct vision	Total of all reporting groups
Overall Participants	18	19	16	53
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	10	11	11	11
Sex: Female, Male (Count of Participants)
Female	7 38.9%	11 57.9%	8 50%	26 49.1%
Male	11 61.1%	8 42.1%	8 50%	27 50.9%
Race/Ethnicity, Customized (Count of Participants)
Chinese	18 100%	19 100%	16 100%	53 100%
Region of Enrollment (Count of Participants)
China	18 100%	19 100%	16 100%	53 100%
Axial length (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	24.83 (0.881)	24.62 (0.772)	24.72 (0.850)	24.72 (0.823)

Outcome Measures

1. Primary Outcome

Title	Change in Axial Length
Description	To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects
Time Frame	Baseline, 7 months, and 14 months after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-vision Glasses and Ortho-k Lenses	Ortho-k Lenses	Single-vision Glasses
Arm/Group Description	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision	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 single-vision glasses: daily wear of spectacle glasses to correct vision
Measure Participants	15	16	13
Phase I (first 7 months)	0.153 (0.021)	0.087 (0.020)	0.082 (0.022)
Phase II (last 7 months)	0.059 (0.014)	0.068 (0.013)	0.064 (0.015)

2. Secondary Outcome

Title	Incidence of Adverse Effects
Description	The observation of serious and non-serious adverse events in the 14 months of study period
Time Frame	14 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single-vision Glasses and Ortho-k Lenses	Ortho-k Lenses	Single-vision Glasses
Arm/Group Description	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision	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 single-vision glasses: daily wear of spectacle glasses to correct vision
Measure Participants	18	19	16
Serious adverse events	0 0%	0 0%	0 0%
non-serious adverse events	1 5.6%	0 0%	0 0%

Adverse Events

Time Frame	Adverse effect data were collected within 2 months after completion of the study for subjects on ortho-k. The subjects were asked to return the contact lenses upon completion of the study and were dismissed once their refractive error and corneal shape were stabilized after cessation of ortho-k treatment. The time required was less than 2 months for all subjects.
Arm/Group Title	Single-vision Glasses and Ortho-k Lenses		Ortho-k Lenses		Single-vision Glasses
Arm/Group Description	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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision single-vision glasses: daily wear of spectacle glasses to correct vision		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 ortho-k lenses: nightly wear of orthokeratology lenses to correct vision		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 single-vision glasses: daily wear of spectacle glasses to correct vision
All Cause Mortality
	Single-vision Glasses and Ortho-k Lenses		Ortho-k Lenses		Single-vision Glasses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Single-vision Glasses and Ortho-k Lenses		Ortho-k Lenses		Single-vision Glasses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Single-vision Glasses and Ortho-k Lenses		Ortho-k Lenses		Single-vision Glasses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		0/19 (0%)		0/16 (0%)
Eye disorders
Chalazion	1/18 (5.6%)	1	0/19 (0%)	0	0/16 (0%)	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.