Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT03347734
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Double-Blind Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '6 week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hypermetropic grade', 'timeFrame': '6 week', 'description': "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"}, {'measure': 'Near and sharp visual acuity', 'timeFrame': '6 week', 'description': '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.'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 week', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eye exercises', 'convergence exercise', 'hyperopia', 'oculomotor exercise', 'school-age children'], 'conditions': ['Hyperopia']}, 'referencesModule': {'availIpds': [{'url': 'https://en.wikipedia.org/wiki/Bates_method', 'type': 'Clinical Study Report'}], 'references': [{'pmid': '20483844', 'type': 'RESULT', '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.'}, {'pmid': '21334899', 'type': 'RESULT', '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.gaitpost.2011.01.016. Epub 2011 Feb 19.'}, {'pmid': '27329615', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://en.wikipedia.org/wiki/Eyes_exercise', 'label': 'History of eyes exercise'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having hypermetropia eye defects\n* Max. having a 1.50 D astigmatism defect\n* Using glasses\n* Having mental capacity in the level to understand and do exercises\n* Not having systemic disease preventing exercise\n\nExclusion Criteria:\n\n* Having undergone eye surgery\n* Having more than 1.50 D astigmatism defect\n* Not using glasses'}, 'identificationModule': {'nctId': 'NCT03347734', 'briefTitle': 'Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Randomized Controlled, Double-Blind Trial of Investigation of the Effect of Different Eye Exercises on Hypermetropia in School-age Children', 'orgStudyIdInfo': {'id': '10840098-604.01.01- E.14383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Exercises Group (EEG)', 'description': '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.', 'interventionNames': ['Behavioral: Eye exercises group']}, {'type': 'EXPERIMENTAL', 'label': 'Convergence Exercise Group (CEG)', 'description': '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.', 'interventionNames': ['Behavioral: Convergence exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'Oculomotor Exercise Group (OMEG)', 'description': '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.', 'interventionNames': ['Behavioral: Oculomotor Exercise Group (OMEG)']}], 'interventions': [{'name': 'Eye exercises group', 'type': 'BEHAVIORAL', 'description': '* 20 times hot water, 20 times cold water washing face in the morning and evening.\n* Palming; 2 hands are rubbed together and warmed up, and the eyes are closed, and 8 digits are drawn with eyes in darkness.\n* 20 blinks\n* 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.', 'armGroupLabels': ['Eye Exercises Group (EEG)']}, {'name': 'Convergence exercise group', 'type': 'BEHAVIORAL', 'description': '* Close eyes for 15 s,\n* Focus on a point 1 to 1.5 ft away for 10 s,\n* Close eyes for 5 s,\n* Focus on a point 20 ft away for 10 s,\n* Close eyes for 5 s,\n* Focus on a point 1 to 1.5 ft away for 10 s,\n* Blink for 5 s,\n* Close eyes for 5 s.', 'armGroupLabels': ['Convergence Exercise Group (CEG)']}, {'name': 'Oculomotor Exercise Group (OMEG)', 'type': 'BEHAVIORAL', 'description': '* The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still.\n* The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still.\n* The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus.\n* The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes.', 'armGroupLabels': ['Oculomotor Exercise Group (OMEG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol Universty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Candan Algun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Gülay Aras', 'investigatorAffiliation': 'Medipol University'}}}}