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Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children (DOEE1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236742
First Posted: November 9, 2010
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Menicon Co., Ltd.
Information provided by (Responsible Party):
Pauline Cho, The Hong Kong Polytechnic University
Results First Submitted: June 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: ortho-k lenses
Device: single-vision glasses

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

ortho-k lenses: nightly wear of orthokeratology lenses to correct vision

single-vision glasses: daily wear of spectacle glasses to correct vision

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

ortho-k lenses: nightly wear of orthokeratology lenses to correct vision

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

single-vision glasses: daily wear of spectacle glasses to correct vision


Participant Flow:   Overall Study
    Single-vision Glasses and Ortho-k Lenses   Ortho-k Lenses   Single-vision Glasses
STARTED   18   19   16 
COMPLETED   15   16   13 
NOT COMPLETED   3   3   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

ortho-k lenses: nightly wear of orthokeratology lenses to correct vision

single-vision glasses: daily wear of spectacle glasses to correct vision

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

ortho-k lenses: nightly wear of orthokeratology lenses to correct vision

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

single-vision glasses: daily wear of spectacle glasses to correct vision

Total Total of all reporting groups

Baseline Measures
   Single-vision Glasses and Ortho-k Lenses   Ortho-k Lenses   Single-vision Glasses   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   16   53 
Age 
[Units: Years]
Median (Full Range)
 10 
 (10 to 14) 
 11 
 (9 to 12) 
 11 
 (9 to 13) 
 11 
 (9 to 13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  38.9%      11  57.9%      8  50.0%      26  49.1% 
Male      11  61.1%      8  42.1%      8  50.0%      27  50.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Chinese   18   19   16   53 
Region of Enrollment 
[Units: Participants]
       
China   18   19   16   53 
Axial length 
[Units: Mm]
Mean (Standard Deviation)
 24.83  (0.881)   24.62  (0.772)   24.72  (0.850)   24.72  (0.823) 


  Outcome Measures

1.  Primary:   Change in Axial Length   [ Time Frame: 14 months ]

2.  Secondary:   Incidence of Adverse Effects   [ Time Frame: 14 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.


Results Point of Contact:  
Name/Title: Prof Pauline Cho
Organization: The Hong Kong Polytechnic University
phone: +852 2766 6100
e-mail: pauline.cho@polyu.edu.hk


Publications of Results:
Other Publications:

Responsible Party: Pauline Cho, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01236742     History of Changes
Other Study ID Numbers: H-ZG50-1
First Submitted: November 8, 2010
First Posted: November 9, 2010
Results First Submitted: June 13, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017