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Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children

Primary Purpose

Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Eye exercises group
Convergence exercise group
Oculomotor Exercise Group (OMEG)
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring eye exercises, convergence exercise, hyperopia, oculomotor exercise, school-age children

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol Universty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Eye Exercises Group (EEG)

Convergence Exercise Group (CEG)

Oculomotor Exercise Group (OMEG)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Visual acuity
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.

Secondary Outcome Measures

Hypermetropic grade
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
Near and sharp visual acuity
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.
Health-related quality of life
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.

Full Information

First Posted
November 15, 2017
Last Updated
May 9, 2018
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT03347734
Brief Title
Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
Official Title
Randomized Controlled, Double-Blind Trial of Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
eye exercises, convergence exercise, hyperopia, oculomotor exercise, school-age children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Double-Blind Study
Masking
ParticipantOutcomes Assessor
Masking Description
Participants do not have information about treatment content and groups. He is only aware of exercise therapy applied to him.The ophthalmologist performed evaluations without knowledge of the groups in which the participants were included and of exercise therapy administered.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye Exercises Group (EEG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Convergence Exercise Group (CEG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Oculomotor Exercise Group (OMEG)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eye exercises group
Intervention Description
20 times hot water, 20 times cold water washing face in the morning and evening. Palming; 2 hands are rubbed together and warmed up, and the eyes are closed, and 8 digits are drawn with eyes in darkness. 20 blinks Looking at a clock in a circular shape, from 12 to 6, from 6 to 12, from 3 to 9, from 9 to 3, from 2 to 8, from 8 to 2, oblique from 10 to 4, from 4 to 10, and turning the eyes starting from 12 clockwise and counterclockwise. At the end of the exercises, 2-3 minutes of light massage around the eyes and on sunny days, sunbathing was recommended by closing the eyes for 3-5 minutes and swinging to the left and right.
Intervention Type
Behavioral
Intervention Name(s)
Convergence exercise group
Intervention Description
Close eyes for 15 s, Focus on a point 1 to 1.5 ft away for 10 s, Close eyes for 5 s, Focus on a point 20 ft away for 10 s, Close eyes for 5 s, Focus on a point 1 to 1.5 ft away for 10 s, Blink for 5 s, Close eyes for 5 s.
Intervention Type
Behavioral
Intervention Name(s)
Oculomotor Exercise Group (OMEG)
Intervention Description
The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still. The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still. The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus. The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes.
Primary Outcome Measure Information:
Title
Visual acuity
Description
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.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Hypermetropic grade
Description
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
Time Frame
6 week
Title
Near and sharp visual acuity
Description
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.
Time Frame
6 week
Title
Health-related quality of life
Description
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.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candan Algun
Organizational Affiliation
Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol Universty
City
Istanbul
State/Province
Beykoz
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20483844
Citation
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.
Results Reference
result
PubMed Identifier
21334899
Citation
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.
Results Reference
result
PubMed Identifier
27329615
Citation
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.
Results Reference
result
Links:
URL
https://en.wikipedia.org/wiki/Eyes_exercise
Description
History of eyes exercise
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://en.wikipedia.org/wiki/Bates_method

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Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children

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