HyperopiaNCT03347734
Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
A study testing Eye exercises group, Convergence exercise group and Oculomotor Exercise Group (OMEG) in people with Hyperopia, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia
- What is being tested?
- Eye exercises group, Convergence exercise group and Oculomotor Exercise Group (OMEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Having undergone eye surgery
- Having more than 1.50 D astigmatism defect
- Not using glasses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperopia
- Being tested
- Eye exercises group, Convergence exercise group, Oculomotor Exercise Group (OMEG)
- Keywords
- eye exercises, convergence exercise, hyperopia, oculomotor exercise, school-age children
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye exercises groupBehavioural
- 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 groupBehavioural
- 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)Behavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Oculomotor Exercise Group (OMEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (3)
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
Measured: 6 week
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.
Measured: 6 week
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Feb 2017
- Primary completion14 Jun 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Double-Blind Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras, Medipol University
- Investigators
- Candan Algun, Study director, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347734
- Sponsor's protocol ID
- 10840098-604.01.01- E.14383
- Status last verified
- May 2018
- First submitted
- 15 Nov 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20483844Morimoto 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.
PubMed 21334899Kang 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.
PubMed 27329615
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Double-Blind Trial of Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
- ClinicalTrials.gov ID
- NCT03347734
- Acronym / sponsor ID
- 10840098-604.01.01- E.14383
- Conditions
- Hyperopia
- Keywords
- eye exercises, convergence exercise, hyperopia, oculomotor exercise, school-age children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Double-Blind Study
| Arm | Type | Receives |
|---|---|---|
| Eye Exercises Group (EEG) | Experimental | Behavioral: Eye exercises groupFor 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. |
| Convergence Exercise Group (CEG) | Experimental | Behavioral: Convergence exercise groupFor 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. |
| Oculomotor Exercise Group (OMEG) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Having undergone eye surgery
- Having more than 1.50 D astigmatism defect
- Not using glasses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Eye Exercises Group (EEG) |
| 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. | Behavioural | Convergence Exercise Group (CEG) |
| 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. | Behavioural | Oculomotor Exercise Group (OMEG) |
Primary outcome
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.
3 secondary outcomes
Hypermetropic grade
Time frame: 6 week
Near and sharp visual acuity
Time frame: 6 week
Health-related quality of life
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Results publication: PubMed 20483844Langer 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 publication: PubMed 21334899Morimoto 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 publication: PubMed 27329615Kang 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.
- History of eyes exerciseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candan Algun study director
Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye exercises group, Convergence exercise group and Oculomotor Exercise Group (OMEG) in people with Hyperopia, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347734, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.