Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 3:10 PM
Study NCT ID:
NCT00785135
Status:
TERMINATED
Last Update Posted:
2020-10-12
First Post:
2008-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D001248', 'term': 'Asthenopia'}, {'id': 'D009041', 'term': 'Motion Sickness'}, {'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D004172', 'term': 'Diplopia'}, {'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D000379', 'term': 'Agoraphobia'}, {'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-11-03', 'lastUpdatePostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms', 'timeFrame': 'Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed'}], 'secondaryOutcomes': [{'measure': 'Evidence that a new survey tool developed by the authors to assess changes / improvement in dizziness, headache and anxiety associated with Vertical Heterophoria correlates to validated, self-administered survey tools for these same symptoms', 'timeFrame': 'New survey tool to be administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vision, binocular', 'vision disparity', 'headache', 'dizziness', 'anxiety', 'neck pain', 'learning disorders', 'asthenopia', 'motion sickness', 'depth perception', 'gait disorder', 'diplopia', 'photophobia', 'agoraphobia', 'panic disorder'], 'conditions': ['Binocular Dysfunction', 'Vertical Heterophoria', 'Vision, Binocular', 'Vision Disparity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription.\n\nThe experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria\n* Must have symptoms of dizziness or headache or both:\n\n * Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness\n * Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes\n* Duration of symptoms greater than 4 months\n* Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\\&R, Ophthalmology).\n* Age \\>14\n* The patient (or their representative) must be able and willing to fill out extra paperwork\n* All Patients to be seen by same Optometrist for all visits\n* Must be willing to wear glasses.\n* The patient (or their representative) must be able to sign informed consent\n* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated\n* Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated\n* Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness\n\nExclusion Criteria:\n\n* Previous diagnosis of strabismus, vertical heterotropia, CN 3, 4 or 6 palsy, "lazy eye"\n* Previous eye injury or eye operation (including RK and Lasik)\n* Diagnosis of glaucoma\n* Diagnosis of cataracts\n* Diagnosis of proptosis\n* Previous C-spine surgery / fusion\n* Previous Rx contains prismatic correction\n* \\>18 PD of exophoria\n* \\> 4 PD of vertical heterophoria on Initial Exam'}, 'identificationModule': {'nctId': 'NCT00785135', 'briefTitle': 'Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria', 'organization': {'class': 'OTHER', 'fullName': 'Vision Specialists of Birmingham'}, 'officialTitle': 'Effects of Vertical Prism on the Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria: A Randomized, Double-blinded, Placebo-controlled, Cross-over Study', 'orgStudyIdInfo': {'id': 'VSofB 20081276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard (Treatment)', 'interventionNames': ['Device: Lenses containing prismatic correction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo (control)', 'interventionNames': ['Device: Lenses not containing prismatic correction']}], 'interventions': [{'name': 'Lenses containing prismatic correction', 'type': 'DEVICE', 'description': 'The patient will receive lenses containing prismatic correction for heterophoria, as well as correction for hyperopia, myopia and astigmatism as indicated during initial examination.', 'armGroupLabels': ['Standard (Treatment)']}, {'name': 'Lenses not containing prismatic correction', 'type': 'DEVICE', 'description': 'The patient will receive lenses containing correction for hyperopia, myopia and astigmatism as indicated during initial examination. The patient will not receive prismatic correction in these lenses.', 'armGroupLabels': ['Placebo (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48009', 'city': 'Birmingham', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vision Specialists of Birmingham', 'geoPoint': {'lat': 42.5467, 'lon': -83.21132}}], 'overallOfficials': [{'name': 'Mark S Rosner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vision Specialists of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vision Specialists of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Essilor International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}