Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT06748534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-22', 'studyFirstSubmitDate': '2024-12-14', 'studyFirstSubmitQcDate': '2024-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocular and Binocular Accommodative Facility (MAF/BAF)', 'timeFrame': '12 Months', 'description': 'Improvement in accommodative facility measured using Monocular and Binocular Accommodative Facility (MAF/BAF) tests with ±2.00 D flipper lenses. Measurement is recorded in cycles per minute (cpm).'}, {'measure': 'subjective measures of visual comfort', 'timeFrame': '12 Months', 'description': 'Reduction in symptoms of accommodative infacility assessed using a customized performa. Measurement is based on a symptom severity score recorded pre- and post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accommodative Insufficiency']}, 'descriptionModule': {'briefSummary': "This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.", 'detailedDescription': 'The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 15 to 35 years.\n* Diagnosed with accommodative infacility.\n* Capable of adhering to the full study duration of 6 weeks.\n* Measurable accommodative dysfunction confirmed through baseline eye examinations.\n* Written informed consent from participants or guardians.\n\nExclusion Criteria:\n\n* Presence of other significant ocular or neurological conditions.\n* Inability or unwillingness to adhere to the prescribed treatment.\n* Prior treatment for accommodative infacility within the past 6 months.\n* Significant uncorrected refractive errors.\n* Medical contraindications for using plus lenses or vision therapy.'}, 'identificationModule': {'nctId': 'NCT06748534', 'briefTitle': 'Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group I', 'interventionNames': ['Diagnostic Test: Plus Lens Addition (+0.75 D)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional group II', 'interventionNames': ['Combination Product: Vision Therapy Using HART Chart']}], 'interventions': [{'name': 'Plus Lens Addition (+0.75 D)', 'type': 'DIAGNOSTIC_TEST', 'description': "Participants in this group were provided with +0.75 D lenses, designed to assist in alleviating strain caused by accommodative infacility by reducing the demand on the eye's focusing mechanism.", 'armGroupLabels': ['Interventional group I']}, {'name': 'Vision Therapy Using HART Chart', 'type': 'COMBINATION_PRODUCT', 'description': 'Intervention Details: Participants in this group underwent vision therapy sessions utilizing the HART chart, aimed at enhancing their accommodative flexibility through repetitive focusing exercises.', 'armGroupLabels': ['Interventional group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}