ROMIO: Retardation of Myopia in Orthokeratology

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00962208
• Collaborator: Menicon Co., Ltd. (Industry)
• Enrollment: 102
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: orthokeratology lenses; Device: single-vision spectacle lenses	N/A

Detailed Description

Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Orthokeratology for Myopic Control in Chinese Children - a Randomized Clinical Trial
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: orthokeratology lenses Children wearing orthokeratology at night for correcting of refractive error will be study group	Device: orthokeratology lenses; Nightly use of orthokeratology to correct the refractive error for a period of two years; Other Names: Corneal reshaping therapy Menicon Z Night Lens
Other: single-vision spectacle lenses Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group	Device: single-vision spectacle lenses; Daily use of spectacles to correct the refractive error for a period of two years; Other Names: CR-39 lenses

Outcome Measures

Primary Outcome Measures

1. Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study [2 years]

   Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.

Secondary Outcome Measures

1. Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups [2 years]

2. Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Myopia (refractive sphere): > 0.50D and ≤ 4.00D

• Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D

• Spherical equivalent (SE): > 0.75D and ≤ 4.50D

• 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 for randomization

• Willingness to wear contact lenses or spectacles on a daily basis

• Availability for follow-up for at least 2 years

Exclusion Criteria:

• Strabismus at distance or near

• Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex

• Prior experience with the use of rigid lenses (including orthokeratology)

• Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)

• 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: NCT00962208
• Other Study ID Numbers: H-ZG13
• First Posted: Aug 19, 2009
• Last Update Posted: Oct 28, 2013
• Last Verified: Jul 1, 2013

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

Study Results

Participant Flow

Recruitment Details	Phone screening was conducted on all parents who responded to advertisements in local newspapers during March 2008 and June 2009. Those who passed the screening would be invited to attend the baseline visit at the Optometry Clinic of The Hong Kong Polytechnic University.
Pre-assignment Detail	All subjects who passed the inclusion and exclusion criteria at the baseline visit would be assigend to the treatment according to the randomization log.

Arm/Group Title	Orthokeratology Lenses	Single-vision Spectacle Lenses
Arm/Group Description	Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.	Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
Period Title: Overall Study
STARTED	51	51
COMPLETED	37	41
NOT COMPLETED	14	10

Baseline Characteristics

Arm/Group Title	Orthokeratology Lenses	Single-vision Spectacle Lenses	Total
Arm/Group Description	Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.	Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.	Total of all reporting groups
Overall Participants	51	51	102
Age (Count of Participants)
<=18 years	51 100%	51 100%	102 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.28 (1.10)	9.27 (1.09)	9.28 (1.09)
Sex: Female, Male (Count of Participants)
Female	25 49%	25 49%	50 49%
Male	26 51%	26 51%	52 51%
Region of Enrollment (participants) [Number]
China	51 100%	51 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study
Description	Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Lenses	Single-vision Spectacle Lenses
Arm/Group Description	Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.	Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
Measure Participants	37	41
Mean (Standard Deviation) [mm]	0.36 (0.24)	0.63 (0.26)

2. Secondary Outcome

Title	Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Orthokeratology Lenses		Single-vision Spectacle Lenses
Arm/Group Description	Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.		Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
All Cause Mortality
	Orthokeratology Lenses		Single-vision Spectacle Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Orthokeratology Lenses		Single-vision Spectacle Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Orthokeratology Lenses		Single-vision Spectacle Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.