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

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ClinicalTrials.gov Identifier: NCT03347734
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gülay Aras, Medipol University

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.

Condition or disease Intervention/treatment Phase
Hyperopia Behavioral: Eye exercises group Behavioral: Convergence exercise group Behavioral: Oculomotor Exercise Group (OMEG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Double-Blind Study
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
Official Title: Randomized Controlled, Double-Blind Trial of Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : October 25, 2017

Resource links provided by the National Library of Medicine


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.
Behavioral: Eye exercises group
  • 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.

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.
Behavioral: Convergence exercise group
  • 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.

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.
Behavioral: Oculomotor Exercise Group (OMEG)
  • 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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347734


Locations
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Turkey
Istanbul Medipol Universty
Istanbul, Beykoz, Turkey
Sponsors and Collaborators
Medipol University
Investigators
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Study Director: Candan Algun Faculty of Health Sciences
Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Gülay Aras, Lecturer, Medipol University
ClinicalTrials.gov Identifier: NCT03347734    
Other Study ID Numbers: 10840098-604.01.01- E.14383
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülay Aras, Medipol University:
eye exercises
convergence exercise
hyperopia
oculomotor exercise
school-age children
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases