NCT03347734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

November 15, 2017

Last Update Submit

May 9, 2018

Conditions

Keywords

eye exercisesconvergence exercisehyperopiaoculomotor exerciseschool-age children

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 week

Secondary Outcomes (3)

  • Hypermetropic grade

    6 week

  • Near and sharp visual acuity

    6 week

  • Health-related quality of life

    6 week

Study Arms (3)

Eye Exercises Group (EEG)

EXPERIMENTAL

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

Convergence Exercise Group (CEG)

EXPERIMENTAL

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

Oculomotor Exercise Group (OMEG)

EXPERIMENTAL

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)

Interventions

* 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.

Eye Exercises Group (EEG)

* 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.

Convergence Exercise Group (CEG)

* 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.

Oculomotor Exercise Group (OMEG)

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Having undergone eye surgery
  • Having more than 1.50 D astigmatism defect
  • Not using glasses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol Universty

Istanbul, Beykoz, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Candan Algun

    Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Double-Blind Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

February 1, 2017

Primary Completion

June 14, 2017

Study Completion

October 25, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access

Locations