Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT02150460
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aaaminatu@yahoo.com', 'phone': '+2348037878367', 'title': 'Dr Aminatu Ali AbdulRahman', 'organization': 'National Eye Centre, Kaduna. Nigeria'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection', 'otherNumAtRisk': 50, 'otherNumAffected': 14, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chemosis', 'notes': 'Swelling of the conjunctiva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Taken to Achieve Adequate Akinesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'title': '10 minutes', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 minutes and 15 minutes', 'description': 'Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of \\<4 and was evaluated at 10 and 15 minutes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Supplementary Injection(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Complications of Local Anaesthetic Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'title': 'Deviation of the globe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sunconjunctival haemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chemosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0,10 and 15 minutes', 'description': 'Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc\n\nLocal complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Score for Local Anaesthetic Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Anaesthetic Drug (ml)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '5.40', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 and 15 minutes', 'description': 'Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Total number of injections required to achieve an akinesia score of \\<4', 'unitOfMeasure': 'injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgeon Satisfaction Score for Local Anaesthetic Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '20 minutes', 'description': 'Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Anaesthetic Block to the Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '25 minutes', 'description': 'Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Cataract Surgery (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '8.78', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '8.88', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of surgery', 'description': 'Time interval from conjunctival incision to application of eye pad', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Score for Cataract Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'One-site peribulbar injection'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Two-site peribulbar injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'One-site Peribulbar Injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment\n\nOne-site peribulbar injection: injection into the inferior medial orbital compartment'}, {'id': 'FG001', 'title': 'Two-site Peribulbar Injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments\n\nTwo- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'One-site Peribulbar Injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment\n\nOne-site peribulbar injection: injection into the inferior medial orbital compartment'}, {'id': 'BG001', 'title': 'Two-site Peribulbar Injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments\n\nTwo- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.30', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '62.60', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '63.45', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '61.48', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '57.38', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '59.26', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients aged 50 years and above with age related operable cataracts that presented for elective cataract surgery during the study period'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-15', 'studyFirstSubmitDate': '2014-05-26', 'resultsFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2014-05-26', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-15', 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Taken to Achieve Adequate Akinesia', 'timeFrame': '10 minutes and 15 minutes', 'description': 'Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of \\<4 and was evaluated at 10 and 15 minutes.'}, {'measure': 'Supplementary Injection(s)', 'timeFrame': '5 minutes', 'description': 'After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later'}, {'measure': 'Complications of Local Anaesthetic Injection', 'timeFrame': '0,10 and 15 minutes', 'description': 'Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc\n\nLocal complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc'}, {'measure': 'Pain Score for Local Anaesthetic Injection', 'timeFrame': '20 minutes', 'description': 'Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain'}, {'measure': 'Pain Score for Cataract Surgery', 'timeFrame': '20 minutes', 'description': 'Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain'}], 'secondaryOutcomes': [{'measure': 'Volume of Anaesthetic Drug (ml)', 'timeFrame': '10 and 15 minutes', 'description': 'Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery'}, {'measure': 'Total Number of Injections', 'timeFrame': '15 minutes', 'description': 'Total number of injections required to achieve an akinesia score of \\<4'}, {'measure': 'Surgeon Satisfaction Score for Local Anaesthetic Block', 'timeFrame': '20 minutes', 'description': 'Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)'}, {'measure': 'Acceptability of the Anaesthetic Block to the Subject', 'timeFrame': '25 minutes', 'description': 'Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye'}, {'measure': 'Duration of Cataract Surgery (Minutes)', 'timeFrame': 'At the end of surgery', 'description': 'Time interval from conjunctival incision to application of eye pad'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ophthalmic surgery, peribulbar local anaesthesia'], 'conditions': ['Anaesthesia', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare the efficacy and safety of single injection peribulbar anaesthesia against the classic double injection technique.\n\nThis was a double blind randomized controlled trial involving two groups of consenting, adult Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the subjects to the two groups administered all the injections. The same surgeon operated on all the subjects while the principal investigator and a research assistant measured the outcome variables. All others were blinded as to subject allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 years and above\n* Diagnosed with uncomplicated senile cataract\n* Visual acuity of \\<3/60\n\nExclusion Criteria:\n\n* Impaired mental status\n* Difficulty in speaking\n* Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase\n* Previous surgery in the same eye\n* Glaucoma\n* Impaired ocular motility\n* Eyelid abnormalities\n* Patients with only one eye'}, 'identificationModule': {'nctId': 'NCT02150460', 'briefTitle': 'A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Eye Centre, Kaduna'}, 'officialTitle': 'A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at National Eye Centre, Kaduna. Nigeria', 'orgStudyIdInfo': {'id': 'NECKAD/TRIALS/001/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One-site peribulbar injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment', 'interventionNames': ['Procedure: One-site peribulbar injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two-site peribulbar injection', 'description': 'Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments', 'interventionNames': ['Procedure: Two- site peribulbar injection']}], 'interventions': [{'name': 'One-site peribulbar injection', 'type': 'PROCEDURE', 'description': 'injection into the inferior medial orbital compartment', 'armGroupLabels': ['One-site peribulbar injection']}, {'name': 'Two- site peribulbar injection', 'type': 'PROCEDURE', 'description': 'Two injections into the infero-temporal and supero-nasal orbital compartments', 'armGroupLabels': ['Two-site peribulbar injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '800001', 'city': 'Kaduna', 'state': 'Kaduna State', 'country': 'Nigeria', 'facility': 'National Eye Centre', 'geoPoint': {'lat': 10.52641, 'lon': 7.43879}}], 'overallOfficials': [{'name': 'Aminatu A AbdulRahman, MBBS, FWACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Eye Centre, Kaduna'}, {'name': 'Mahmoud B Alhassan, MBBS, FWACS', 'role': 'STUDY_CHAIR', 'affiliation': 'National Eye Centre, Kaduna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Eye Centre, Kaduna', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}