Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT07012512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015877', 'term': 'Miosis'}], 'ancestors': [{'id': 'D011681', 'term': 'Pupil 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-31', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversal of pupillary dilatation', 'timeFrame': 'Hourly for four hours after administration of the drug'}], 'secondaryOutcomes': [{'measure': 'Recovery of accommodation after instillation of the drop', 'timeFrame': 'Hourly for four hours after administration of the drug'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pupillary Constriction', 'Accomodation']}, 'descriptionModule': {'briefSummary': 'The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.', 'detailedDescription': 'To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).\n\nInterventions\n\nCycloplegia Induction:\n\nBoth eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).\n\nReversal Agents (administered at 30 minutes post-cyclopentolate):\n\nPilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.\n\nPhentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.\n\nCombination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 5 and 12 years undergoing cycloplegia\n\nExclusion Criteria:\n\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT07012512', 'briefTitle': 'Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children', 'orgStudyIdInfo': {'id': 'Mansoura university Ophthalmic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilocarpine group', 'description': 'Children will receive pilocarpine drops in one eye and placebo in the other', 'interventionNames': ['Drug: Pilocarpine 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phentolamine group', 'description': 'Children will receive phentolamine eye drop in one eye and placebo in the other', 'interventionNames': ['Drug: Use of phentolamine eye drops to reverse cycloplegia']}, {'type': 'EXPERIMENTAL', 'label': 'Combined', 'description': 'Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other', 'interventionNames': ['Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%']}], 'interventions': [{'name': 'Use of phentolamine eye drops to reverse cycloplegia', 'type': 'DRUG', 'description': 'Use of phentolamine 0.75% eye drops to reverse cycloplegia', 'armGroupLabels': ['Phentolamine group']}, {'name': 'Pilocarpine 0.1%', 'type': 'DRUG', 'description': 'Use of pilocarpine 0.1% to reverse cycloplegia', 'armGroupLabels': ['Pilocarpine group']}, {'name': 'Combination of pilocarpine 0.1% and phentolamine 0.75%', 'type': 'DRUG', 'description': 'Combination of pilocarpine 0.1% and phentolamine 0.75%', 'armGroupLabels': ['Combined']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed AlNagdy', 'role': 'CONTACT', 'email': 'imanatta@mans.edu.eg', 'phone': '+201096710982'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}