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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347734
Other study ID # 10840098-604.01.01- E.14383
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date October 25, 2017

Study information

Verified date May 2018
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 25, 2017
Est. primary completion date June 14, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Turkey Istanbul Medipol Universty Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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.gaitp — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 6 week
Secondary 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. 6 week
Secondary 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. 6 week
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