Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05890027
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001763', 'term': 'Blepharoptosis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'swester2@med.miami.edu', 'phone': '(305)-243-2020', 'title': 'Dr. Sara T. Wester', 'organization': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'This eye-based study treated each ptotic eye as an individual unit. Bilateral ptosis participants contributed two eyes; unilateral ptosis participants contributed one eye. All eyes underwent identical sequential interventions and assessments in this single-arm study. Since all participants received the same intervention sequence, adverse events are reported under one arm: "all study participants."', 'eventGroups': [{'id': 'EG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nAll recruited eyes progressed through all testing conditions (baseline, taping, and phenylephrine ophthalmic solution).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean MRD1 After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after phenylephrine instillation.', 'description': 'Margin to Reflex Distance 1 measured at least ten minutes after administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye. Measured in mm.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Mean Change in MRD1 Between Baseline and Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '1.59'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Mean Superior Visual Field After Taping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.40', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Mean Change in Superior Visual Field After Taping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.20', 'spread': '3.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Count of Eyes That Met Insurance Criteria After Taping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'title': 'Achieved min 12 degree improvement', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Did not achieve min 12 degree improvement', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).\n\nHere we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and taping of the upper eyelid.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Mean Superior Visual Field After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.27', 'spread': '3.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after phenylephrine instillation.', 'description': 'Degree of ptosis as measured by a tangent screen superior visual field test ten minutes after the administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Mean Change in Superior Visual Field After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.07', 'spread': '3.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Count of Eyes That Met Insurance Criteria After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'title': 'Achieved min 12 degree improvement', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Did not achieve min 12 degree improvement', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).\n\nHere we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and phenylephrine ophthalmic solution instillation.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'SECONDARY', 'title': 'Mean Participant Satisfaction Score After Taping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.69', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Participant Satisfaction Score After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.38', 'spread': '0.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.97'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments in a single arm, sequential design as outlined below.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential interventions and assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using adhesive tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment:\n\nFollowing completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'preAssignmentDetails': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. This was a single-arm study in which all recruited eyes progressed sequentially through identical interventions and assessments as described in the Arm/Group Description.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This study used an eye-based unit of analysis, where each eye with ptosis served as an individual study unit. Participants with bilateral ptosis contributed two eyes to the study, while those with unilateral ptosis contributed one eye. All affected eyes underwent identical interventions and assessments.\n\nStudy Protocol:\n\nEach eye with ptosis underwent the following sequential assessments:\n\n1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.\n2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.\n3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.\n\nThe total duration for each participant was less than 60 minutes across all testing conditions.\n\nPost-Study Assessment: Following completion of all interventions, participants completed a satisfaction questionnaire using a 5-point Likert scale to evaluate their experience with both eyelid taping and phenylephrine administration.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>18 years old', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Baseline MRD1', 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'eyes'}, {'title': 'Baseline Superior Visual Field', 'classes': [{'categories': [{'measurements': [{'value': '7.20', 'spread': '2.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'eyes'}], 'typeUnitsAnalyzed': 'eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-24', 'size': 347243, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-25T16:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-05-25', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2023-05-25', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-01', 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean MRD1 After Phenylephrine', 'timeFrame': '10 minutes after phenylephrine instillation.', 'description': 'Margin to Reflex Distance 1 measured at least ten minutes after administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye. Measured in mm.'}, {'measure': 'Mean Change in MRD1 Between Baseline and Phenylephrine', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.'}, {'measure': 'Mean Superior Visual Field After Taping', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.'}, {'measure': 'Mean Change in Superior Visual Field After Taping', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.'}, {'measure': 'Count of Eyes That Met Insurance Criteria After Taping', 'timeFrame': 'Baseline, Within 1 minute after upper eyelid taping.', 'description': 'Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).\n\nHere we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and taping of the upper eyelid.'}, {'measure': 'Mean Superior Visual Field After Phenylephrine', 'timeFrame': '10 minutes after phenylephrine instillation.', 'description': 'Degree of ptosis as measured by a tangent screen superior visual field test ten minutes after the administration of a single drop of 2.5% phenylephrine ophthalmic solution into the superior conjunctival fornix of the eye.'}, {'measure': 'Mean Change in Superior Visual Field After Phenylephrine', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.'}, {'measure': 'Count of Eyes That Met Insurance Criteria After Phenylephrine', 'timeFrame': 'Baseline, 10 minutes after phenylephrine instillation.', 'description': 'Insurance SVF criteria for determining if ptosis is functionally significant are based on the absolute SVF height in primary gaze (a superior visual field of 30 degrees or less from fixation at baseline) and the difference in SVF demonstrated by taping of the upper eyelids (improvement of at least 12 degrees in the superior visual field compared to baseline).\n\nHere we assessed the count of units, with units being eyes, that demonstrated an improvement of at least 12 degrees in superior visual field between baseline and phenylephrine ophthalmic solution instillation.'}], 'secondaryOutcomes': [{'measure': 'Mean Participant Satisfaction Score After Taping', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.'}, {'measure': 'Mean Participant Satisfaction Score After Phenylephrine', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.'}, {'measure': 'Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine', 'timeFrame': 'Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.', 'description': 'After completing the testing, participants completed a post-study questionnaire using a 5-point Likert scale (5=excellent, 4=good, 3=average, 2=poor, 1=very poor) to rate their satisfaction and overall experience with both upper eyelid taping and 2.5% phenylephrine ophthalmic solution instillation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ptosis, Eyelid']}, 'descriptionModule': {'briefSummary': 'This research study aims to compare whether Phenylephrine 2.5% ophthalmic eye drop solution can serve as a better indicator of the effect of a drooping upper eyelid (ptosis) by covering part of the upper portion of the field of vision as compared to traditional use of tape to lift up the upper eyelid in the evaluation of patients for surgical upper eyelid repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals diagnosed with ptosis undergoing conjunctival Muller's muscle resection evaluation.\n* Individuals who can tolerate and have no hypersensitivity to phenylephrine 2.5% ophthalmic solution.\n* Individuals who can tolerate eye-drop medications.\n* Individuals who are physically able to take a tangent screen visual field test.\n* Age: Adults who can comprehend the instructions and procedures (18+ years old)\n\nExclusion Criteria:\n\n\\- This study will not incorporate any of the following at-risk populations: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.\n\n* This study will not include participants who refuse to consent.\n* This study will not include participants who are too tired or unable to take a tangent screen visual field test (see Risk to Subjects).\n* This study will not include individuals who may not be able to tolerate phenylephrine 2.5% ophthalmic solution.\n* Specifically, those with a past medical history of bradycardia, hypotension, autonomic dysfunction, or severe cardiovascular disease\n* This study will not include individuals who consume drugs contraindicated in phenylephrine use: Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates), Iobenguane Radiopharmaceutical Products, Kratom, Lisuride, Monoamine Oxidase Inhibitors"}, 'identificationModule': {'nctId': 'NCT05890027', 'briefTitle': "Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation", 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': "Phenylephrine Versus Upper Eyelid Taping For Muller's Muscle Conjunctival Resection Evaluation", 'orgStudyIdInfo': {'id': '20230019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenylephrine and Eye Taping Group', 'description': 'Participants in this group will initially have superior visual field testing done with the upper eyelid manually taped. Then, participants will have superior visual field testing done after receiving Phenylephrine 2.5% ophthalmic solution. Participants will be in each group for up to 60 minutes.', 'interventionNames': ['Drug: Phenylephrine Ophthalmic', 'Other: Eyelid Tape']}], 'interventions': [{'name': 'Phenylephrine Ophthalmic', 'type': 'DRUG', 'description': 'One drop of Phenylephrine 2.5% ophthalmic solution to be administered to the eye with ptosis to evaluate for surgical repair.', 'armGroupLabels': ['Phenylephrine and Eye Taping Group']}, {'name': 'Eyelid Tape', 'type': 'OTHER', 'description': 'Participants will have the affected eye with ptosis manually lifted using tape.', 'armGroupLabels': ['Phenylephrine and Eye Taping Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Sara T Wester, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical', 'investigatorFullName': 'Sara T. Wester', 'investigatorAffiliation': 'University of Miami'}}}}