Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT01860534
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D015878', 'term': 'Mydriasis'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'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': 'D011681', 'term': 'Pupil Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cageary@utmb.edu', 'phone': '409-772-2815', 'title': 'Dr. Cara Geary', 'organization': 'University of Texas medical Branch, Galveston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'no Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eye Patches Covers (ROP #1 and ROP #2)', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'OG001', 'title': 'no Eye Patches Covers (ROP #1 and ROP #2)', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '154', 'spread': '8', 'groupId': 'OG000'}, {'value': '154', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dilation', 'categories': [{'measurements': [{'value': '152', 'spread': '8', 'groupId': 'OG000'}, {'value': '163', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dilation', 'categories': [{'measurements': [{'value': '154', 'spread': '8', 'groupId': 'OG000'}, {'value': '164', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used', 'unitOfMeasure': 'Beats per minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'OG001', 'title': 'no Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54', 'spread': '13', 'groupId': 'OG000'}, {'value': '47', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dilation', 'categories': [{'measurements': [{'value': '54', 'spread': '13', 'groupId': 'OG000'}, {'value': '52', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dilation', 'categories': [{'measurements': [{'value': '55', 'spread': '11', 'groupId': 'OG000'}, {'value': '50', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used', 'unitOfMeasure': 'Breaths per minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Percent Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'OG001', 'title': 'no Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98', 'spread': '3', 'groupId': 'OG000'}, {'value': '98', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dilation', 'categories': [{'measurements': [{'value': '98', 'spread': '3', 'groupId': 'OG000'}, {'value': '98', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dilation', 'categories': [{'measurements': [{'value': '98', 'spread': '3', 'groupId': 'OG000'}, {'value': '98', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used', 'unitOfMeasure': 'percent saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'OG001', 'title': 'no Eye Patches Covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': '1 hour post dilation', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '3 hour post dilation', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores \\> to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eye Patch Initially Then no Eye Patch', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.'}, {'id': 'FG001', 'title': 'no Eye Patches Initially Then Eye Patches', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.'}], 'periods': [{'title': 'ROP #1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Needed treatment for ROP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'ROP #2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'discharged prior to ROP #2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'July 2011 to september 2012. At the University of Texas medical Branch.', 'preAssignmentDetails': '60 neonates were excluded prior to randomization since they did not meet inclusion criteria, refused to participate or other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eye Patches Initially Then no Patches', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'BG001', 'title': 'no Eye Patches Initially Then Eye Patches', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.04', 'groupId': 'BG000'}, {'value': '0.53', 'spread': '0.04', 'groupId': 'BG001'}, {'value': '0.53', 'spread': '0.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2013-05-20', 'resultsFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-08', 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used'}, {'measure': 'Oxygen Percent Saturation', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used'}, {'measure': 'Pain', 'timeFrame': 'pre-mydriasis, 1 hour and 3 hours after mydriatic drops', 'description': 'At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores \\> to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'mydriasis', 'light'], 'conditions': ['Light Sensitivity']}, 'descriptionModule': {'briefSummary': 'Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.', 'detailedDescription': 'Pain management for Retinopathy of prematurity (ROP) screening focuses on pharmacological and non-pharmacological interventions during the actual eye examination. Management of pain related to increased light sensitivity during the post-mydriasis period has not been described.\n\nThis prospective, randomized study evaluated the impact of protecting the eyes from ambient light exposure post mydriasis. Vital signs and pain scales were recorded in infants randomized to either wear or not wear eye patches after mydriasis for their ROP exam. Infants less than 30 weeks gestational age or less than 1500 grams at birth were included. Standard statistical methods were used to compare vital signs and pain scores for each group at baseline, 1 and 3 hours after mydriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants with gestational age at birth of 30 weeks or less or with birth weight less than 1500g undergoing their first ROP exam in the Infant Special Care Unit (ISCU) at UTMB.\n\nExclusion Criteria:\n\n* Infants were excluded if they had any congenital malformation or syndrome; a history of eye surgery or were receiving inotropics medications.'}, 'identificationModule': {'nctId': 'NCT01860534', 'briefTitle': '"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': '"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"', 'orgStudyIdInfo': {'id': '11-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye patches covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.', 'interventionNames': ['Behavioral: eye covers']}, {'type': 'NO_INTERVENTION', 'label': 'no eye patches covers', 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.'}], 'interventions': [{'name': 'eye covers', 'type': 'BEHAVIORAL', 'otherNames': ['eye patches (Natus biliband)'], 'description': 'The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.', 'armGroupLabels': ['Eye patches covers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Erika M. Espino-Torres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}