- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347734
Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
May 9, 2018 updated by: Gülay Aras, Medipol University
Randomized Controlled, Double-Blind Trial of Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
Hypermetropia in school-aged children is a pathology which is very common and responds to treatments early.
No studies have been found in the literature on the efficancy of the hypermetropia treatments with physiotherapy methods.
In our study, it was aimed to investigate the effects of different eye exercises on hypermetropia defects in school age children aged 7-17 years and to determine whether exercise protocols have superiority against each other.
Study Overview
Status
Completed
Conditions
Detailed Description
60 volunteer school-aged children (30 girls, 30 boys, between 7-17 years of age) were included in our study.
60 participants were randomly divided into three groups: eye exercises, convergence exercises and oculomotor exercise groups.
Home exercise protocols were given to all groups for 2 sessions per day for 6 weeks, and regular phone calls were made once a week.
Participants were assessed for their hypermetropic grades by autorefractometry, visual acuity by snellen chart, near and sharp visual acuity by activities of daily vision scale, and the health-related quality of life by pediatric quality of life inventory 4.0 version (PEDSQI 4.0) children report.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey
- Istanbul Medipol Universty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having hypermetropia eye defects
- Max. having a 1.50 D astigmatism defect
- Using glasses
- Having mental capacity in the level to understand and do exercises
- Not having systemic disease preventing exercise
Exclusion Criteria:
- Having undergone eye surgery
- Having more than 1.50 D astigmatism defect
- Not using glasses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eye Exercises Group (EEG)
For the individuals in the group of eye exercises (GEG), 10 repetitive eye exercises protocol was organized as a home program for 6 weeks, twice a day in the morning and evening each day of the week.
|
|
|
Experimental: Convergence Exercise Group (CEG)
For the individuals in the group of convergence exercise, 5 minutes convergence exercise protocol was organized as a home program for 6 weeks, twice a day in the morning and evening each day of the week.
|
|
|
Experimental: Oculomotor Exercise Group (OMEG)
For the individuals in the group of oculomotor exercise, 10 repetitive, four different oculomotor exercise protocols with eye stabilization were organized as home programs for 6 weeks, twice a day in the morning and evening each day of the week.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual acuity
Time Frame: 6 week
|
Snellen chart was used for visual acuity measurement.
Snellen "E" was asked to be registered or registered to the device.
In visual acuity measurement, individuals were evaluated with their own glasses.
|
6 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypermetropic grade
Time Frame: 6 week
|
The refraction defects were measured by autorefractometry, which is frequently used because it provides fast and reliable results in clinic.
In the autorefractometry method, the infrared rays sent to the patient's eye are reflected from the retina back to the device and evaluate the refraction defect of the patient
|
6 week
|
|
Near and sharp visual acuity
Time Frame: 6 week
|
Subscales of activities of daily vision scale, individuals questioning the near vision and sharp vision scores were used.
Individuals question the extent to which they can not perform activities because of the difficulty of seeing them, and the degree of difficulty they experience while doing the activity.
Points in different categories are summed and converted to a value between 0-100 by the formula.
High score gives good visual acuity.
|
6 week
|
|
Health-related quality of life
Time Frame: 6 week
|
Participants' health-related quality of life was assessed using the Pediatric Quality of Life Inventory Version 4.0 (PedSQI 4.0) Children Report.
Score is calculated in 3 areas as total score of scale (SST), total physical health score (FSTP) and total score of psychosocial health (PSTP) which is calculated by calculating emotional, social and school functioning.
|
6 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Candan Algun, Faculty of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.
- Langer E, Djikic M, Pirson M, Madenci A, Donohue R. Believing is seeing: using mindlessness (mindfully) to improve visual acuity. Psychol Sci. 2010 May;21(5):661-6. doi: 10.1177/0956797610366543. Epub 2010 Mar 19.
- Kang MT, Li SM, Peng X, Li L, Ran A, Meng B, Sun Y, Liu LR, Li H, Millodot M, Wang N. Chinese Eye Exercises and Myopia Development in School Age Children: A Nested Case-control Study. Sci Rep. 2016 Jun 22;6:28531. doi: 10.1038/srep28531.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
June 14, 2017
Study Completion (Actual)
October 25, 2017
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
May 9, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01- E.14383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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