Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

Myopia Clinical Trial

— DOEE1  

Official title:

Discontinuation of Orthokeratology on Eyeball Elongation (DOEE) Study. (1) Discontinuation of Lens Wear in Existing Ortho-k Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236742
• Other study ID #: H-ZG50-1
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: November 9, 2017
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2017
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• ortho-k lenses
nightly wear of orthokeratology lenses to correct vision
• single-vision glasses
daily wear of spectacle glasses to correct vision

Locations

Country	Name	City	State
China	School of Optometry, The Hong Kong Polytechnic University	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Menicon Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Adverse Effects	The observation of serious and non-serious adverse events in the 14 months of study period	14 months