Trial Outcomes & Findings for Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation (NCT NCT05890027)
NCT ID: NCT05890027
Last Updated: 2025-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
10 minutes after phenylephrine instillation.
Results posted on
2025-08-22
Participant Flow
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.
Unit of analysis: eyes
Participant milestones
| Measure |
All Study Participants
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.
Study Protocol:
Each eye with ptosis underwent the following sequential interventions and assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using adhesive tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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Overall Study
STARTED
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18 32
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Overall Study
COMPLETED
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18 32
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phenylephrine Versus Eyelid Taping for Muller's Muscle-Conjunctival Resection (MMCR) Evaluation
Baseline characteristics by cohort
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Age, Customized
>18 years old
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18 Participants
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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11 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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18 Participants
n=5 Participants
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Baseline MRD1
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0.69 mm
STANDARD_DEVIATION 0.95 • n=32 eyes
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Baseline Superior Visual Field
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7.20 degrees
STANDARD_DEVIATION 2.72 • n=32 eyes
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PRIMARY outcome
Timeframe: 10 minutes after phenylephrine instillation.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.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean MRD1 After Phenylephrine
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2.08 mm
Standard Deviation 0.91
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PRIMARY outcome
Timeframe: Baseline, 10 minutes after phenylephrine instillation.Change in Margin to Reflex Distance 1 between the eye at baseline and after instillation of 2.5% phenylephrine ophthalmic solution. Measured in mm.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Change in MRD1 Between Baseline and Phenylephrine
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1.38 mm
Interval 1.18 to 1.59
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PRIMARY outcome
Timeframe: Baseline, Within 1 minute after upper eyelid taping.Degree of ptosis as measured by a tangent screen superior visual field test after taping of the upper eyelid.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Superior Visual Field After Taping
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21.40 degrees
Standard Deviation 2.69
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PRIMARY outcome
Timeframe: Baseline, Within 1 minute after upper eyelid taping.Mean Change in Superior Visual Field between the eye at baseline and after taping of the upper eyelid. Measured in degrees.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Change in Superior Visual Field After Taping
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14.20 degrees
Standard Deviation 3.53
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PRIMARY outcome
Timeframe: Baseline, Within 1 minute after upper eyelid taping.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). Here 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.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Count of Eyes That Met Insurance Criteria After Taping
Achieved min 12 degree improvement
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27 eyes
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Count of Eyes That Met Insurance Criteria After Taping
Did not achieve min 12 degree improvement
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5 eyes
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PRIMARY outcome
Timeframe: 10 minutes after phenylephrine instillation.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.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Superior Visual Field After Phenylephrine
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22.27 degrees
Standard Deviation 3.56
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PRIMARY outcome
Timeframe: Baseline, 10 minutes after phenylephrine instillation.Change in superior visual field between baseline and 10 minutes after instillation of phenylephrine ophthalmic solution. Measured in degrees.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Change in Superior Visual Field After Phenylephrine
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15.07 degrees
Standard Deviation 3.58
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PRIMARY outcome
Timeframe: Baseline, 10 minutes after phenylephrine instillation.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). Here 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.
Outcome measures
| Measure |
All Study Participants
n=32 eyes
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Count of Eyes That Met Insurance Criteria After Phenylephrine
Achieved min 12 degree improvement
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28 eyes
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Count of Eyes That Met Insurance Criteria After Phenylephrine
Did not achieve min 12 degree improvement
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4 eyes
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SECONDARY outcome
Timeframe: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.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.
Outcome measures
| Measure |
All Study Participants
n=18 Participants
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Participant Satisfaction Score After Taping
|
3.69 score on a scale
Standard Deviation 0.59
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SECONDARY outcome
Timeframe: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.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.
Outcome measures
| Measure |
All Study Participants
n=18 Participants
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Participant Satisfaction Score After Phenylephrine
|
4.38 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, Within 5 minutes after completing SVF testing after phenylephrine instillation.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.
Outcome measures
| Measure |
All Study Participants
n=18 Participants
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.
Study Protocol:
Each eye with ptosis underwent the following sequential assessments:
1. Baseline measurements: Superior visual field (SVF) testing and margin reflex distance 1 (MRD1) measurements were performed with the eyelid in its natural position.
2. Eyelid taping intervention: The upper eyelid was manually elevated using tape, and SVF testing was repeated.
3. Phenylephrine intervention: One drop of 2.5% phenylephrine ophthalmic solution was instilled into the affected eye, followed by both SVF testing and MRD1 measurements.
The total duration for each participant was less than 60 minutes across all testing conditions.
Post-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.
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|---|---|
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Mean Change in Participant Satisfaction Score Between Taping and Phenylephrine
|
0.69 score on a scale
Interval 0.41 to 0.97
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sara T. Wester
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida
Phone: (305)-243-2020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place