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

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.
  • 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.
  • 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.
  • 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.

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.

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.

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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