Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT05208658
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of the Vergence Responses of Binocularly Normal Subjects After a Vision Therapy Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D004948', 'term': 'Esotropia'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'It is measured objectively with an haparoscopic setup and eye movements were recorded with an Eyelink 1000 Plus (SR Research) at 500Hz. Firstly, stimulus disparity changed smoothly at 1PD/s up to 45PD for both divergence (BI) and convergence (BO), mimicking a Risley prism. Secondly, the disparity was changed in steps of 2PD mimicking a prism bar. Break and recovery points were determined offline using a custom Matlab code for the analysis of eye movements.\n\nMeasurements will be compared before and after the therapy treatment.'}, {'measure': 'Subjective vergence response: To evaluate objectively the change in positive and negative fusional vergence at near of binocularly and accommodative normal subjects after performing a vision therapy', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'It is evaluated with the clinical methods measured subjectively using the Risley prism of the phoropter and the Prism Bar.\n\nMeasurements will be compared before and after the therapy treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vergence', 'Vision Therapy', 'Binocular Vision'], 'conditions': ['Vision Disorders', 'Eye; Movement Disorder (Binocular)', 'Vision Therapy', 'Binocular Vision Disorder']}, 'referencesModule': {'references': [{'pmid': '15642806', 'type': 'RESULT', 'citation': 'Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 2005 Jan;123(1):14-24. doi: 10.1001/archopht.123.1.14.'}, {'pmid': '30570596', 'type': 'RESULT', 'citation': 'Scheiman M, Talasan H, Alvarez TL. Objective Assessment of Disparity Vergence after Treatment of Symptomatic Convergence Insufficiency in Children. Optom Vis Sci. 2019 Jan;96(1):3-16. doi: 10.1097/OPX.0000000000001320.'}, {'pmid': '31640452', 'type': 'RESULT', 'citation': "Alvarez TL, Scheiman M, Santos EM, Morales C, Yaramothu C, D'Antonio-Bertagnolli JV, Biswal BB, Gohel S, Li X. The Convergence Insufficiency Neuro-mechanism in Adult Population Study (CINAPS) Randomized Clinical Trial: Design, Methods, and Clinical Data. Ophthalmic Epidemiol. 2020 Feb;27(1):52-72. doi: 10.1080/09286586.2019.1679192. Epub 2019 Oct 22."}, {'pmid': '16044063', 'type': 'RESULT', 'citation': 'Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. 2005 Jul;82(7):583-95. doi: 10.1097/01.opx.0000171331.36871.2f.'}, {'pmid': '29577409', 'type': 'RESULT', 'citation': 'Scheiman M, Chase C, Borsting E, Mitchell GL, Kulp MT, Cotter SA; CITT-RS Study Group. Effect of treatment of symptomatic convergence insufficiency on reading in children: a pilot study. Clin Exp Optom. 2018 Jul;101(4):585-593. doi: 10.1111/cxo.12682. Epub 2018 Mar 25.'}, {'pmid': '18852411', 'type': 'RESULT', 'citation': 'Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336.'}]}, 'descriptionModule': {'briefSummary': 'A vision therapy protocol for vergence ability is mentioned. The purpose of this study is to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol. This study is an interventional, cross-over, and randomized study.', 'detailedDescription': "After the first evaluation, subjects will be classified in the Experimental Group (EG) or Control Group (CG) randomly. There will be 18 subjects in each group. A classic vision therapy protocol for fusional vergence will be performed in the EG and the CG will be doing a placebo therapy, based on studies done before.\n\nThe EG will do weekly office-based therapy of 45 minutes during 12 weeks and the CG will do weekly office-based placebo therapy of 15 minutes during 12 weeks. This placebo therapy will consist of smooth-pursuit and discrimination exercises that do not influence vergence response. The office-based done by the EG consists of a vergence therapy and its protocol will follow Scheiman's indications protocol. This vision therapy will train both positive and negative fusional vergence amplitudes in the same proportion.\n\nA pre-evaluation, a during evaluation, and a post-evaluation will be done at weeks 1, 6, and 12 respectively to all subjects. After the post-evaluation week, the CG will do 12 weeks more of office-based therapy but, this group will do the same conventional vergence protocol as EG. The CG will be evaluated at week 18, and finally, at week 24.\n\nDuring the evaluations, the vergence eye movements will be measured during the positive and negative fusional vergence tests. The break and the recovery points will be evaluated to all the subjects with three different methods performed in a randomized order: (1) objective computer-based test in the haploscopic system, (2) prism bar, and (3) phoropter rotary prisms. All these tests will be performed at 40 cm with a classic central visual target.\n\nThis study aims to evaluate objectively the change in the vergence responses of binocular and accommodative normal subjects after performing a classic vision therapy protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Normal binocular and accommodative subjects will participate in the study. All subjects have to fulfill the inclusion criteria. All evaluations will consist of the following objective and subjective optometric tests, which will be executed for all participants.\n\n1. Monocular and binocular VA at near and distance with their habitual correction\n2. Refractive error measured with the Grand Seiko WAM-5500 Autorefractor\n3. Cover Test at near (40 cm)\n4. Near Point of Accommodation\n5. Near Point of Convergence\n6. Vergence Facility Test at near (40 cm)\n7. Monocular and binocular Accommodation Facility Test at near (40 cm)\n8. Negative and Positive Relative Accommodation Test (ARN and ARP)\n9. Random Dot 2 Stereo acuity Test\n10. CISS questionnaire\n11. Fusional Vergence Amplitude using both subjective and objective methods\n\nExclusion Criteria:\n\n* having eye surgery\n* having an eye pathology\n* having a binocular or an accommodative disorder\n* using orto-K lenses'}, 'identificationModule': {'nctId': 'NCT05208658', 'briefTitle': 'Characteristics of the Vergence Responses of Binocularly Normal Subjects After a Vision Therapy Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Politècnica de Catalunya'}, 'officialTitle': 'Evaluate Objectively the Change in the Vergence Responses of Binocular and Accommodative Normal Subjects After Performing a Classic Vision Therapy Protocol', 'orgStudyIdInfo': {'id': 'Vergence VT Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classical Vision Therapy Treatment: vision therapy exercises for fusional vergence abilities', 'description': "The Experimental Group (EG) it consist in a Classical Vision Therapy Treatment. This group will do weekly office-based therapy of 45 minutes of visual exercises during 12 weeks. The office-based done by the EG consists of a vergence therapy and its protocol will follow Scheiman's Protocol and Indications.\n\nThe exercises do not tough the eye or use drugs. They are just visual training exercises that improve fusional convergence and divergence response.", 'interventionNames': ['Other: Experimental: Classical Vision Therapy Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence', 'description': 'The Control Group or Placebo Group consist in a Control: Eye Movement Therapy Treatment. This group will do weekly office-based placebo therapy of 15 minutes during 12 weeks of visual exercises. This placebo therapy will consist of smooth-pursuit and discrimination exercises that do not influence vergence response.\n\nThe exercises do not tough the eye nor use drugs. They are just visual training exercises that do not improve fusional vergence response as they improve smooth-pursuit eye movements.', 'interventionNames': ['Other: Experimental: Classical Vision Therapy Treatment', 'Other: Control: Eye Movement Therapy Treatment']}], 'interventions': [{'name': 'Experimental: Classical Vision Therapy Treatment', 'type': 'OTHER', 'otherNames': ['Vision therapy protocol'], 'description': 'Do classical vision therapy treatment for improve vergence', 'armGroupLabels': ['Classical Vision Therapy Treatment: vision therapy exercises for fusional vergence abilities', 'Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence']}, {'name': 'Control: Eye Movement Therapy Treatment', 'type': 'OTHER', 'otherNames': ['Vision therapy protocol'], 'description': 'Do eye movement therapy treatment in order not to improve vergence', 'armGroupLabels': ['Eye Movement Therapy Treatment: vision therapy placebo exercises not improve fusional vergence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08222', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Rovira-Gay', 'role': 'CONTACT', 'email': 'cristina.rovira@upc.edu', 'phone': '610072514'}], 'facility': 'Cristina Rovira-Gay', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Politècnica de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Predoctoral student', 'investigatorFullName': 'Cristina Rovira Gay', 'investigatorAffiliation': 'Universitat Politècnica de Catalunya'}}}}