Trial Outcomes & Findings for Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections (NCT NCT02951351)
NCT ID: NCT02951351
Last Updated: 2023-04-12
Results Overview
Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
pre-injection
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Standard Procedure + Culture
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.1 years
n=19 Participants
|
73.2 years
n=17 Participants
|
77.3 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
9 Participants
n=17 Participants
|
22 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
8 Participants
n=17 Participants
|
14 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
17 participants
n=17 Participants
|
36 participants
n=36 Participants
|
|
Injection drug administered
Bevacizumab
|
16 Participants
n=19 Participants
|
10 Participants
n=17 Participants
|
26 Participants
n=36 Participants
|
|
Injection drug administered
Aflibercept
|
3 Participants
n=19 Participants
|
7 Participants
n=17 Participants
|
10 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: pre-injectionConjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Number of Study Participants With Positive Conjunctival Culture
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Pain at the Time of Injection
|
2 score on a scale
Interval 0.0 to 8.0
|
1 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the residual pain, the higher the score, the higher the residual pain.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Residual Pain From Intravitreal Injection
|
1 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the visit, the higher the score, the less positive impression of the visit.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Overall Impression of Visit for Intravitreal Injection
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey consisted of 6 questions and was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the preparation process, the higher the score, the less positive impression of the preparation process..
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Impression of Pre-injection Preparations
|
0 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more comfortable the subject was with the procedure, the higher the score, the less comfortable the subject was with the procedure.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Comfort With Intravitreal Injection Standard Procedure
|
0 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: post-injectionSubjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. A lower score indicated subjects did not expect the injection would negatively affect their overall health. Higher scores indicated subjects expected the injection would negatively affect their overall health.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: post-injectionPatients were asked to rate their expectation on the extent to which the intravitreal injections would contribute to curing or improving their eye condition. The question was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a negative response (not at all) and 10 was a positive response (to a large extent). A low score indicated the subject did not expect the injection would contribute to curing or improving the eye condition while a high score indicated the subject did expect the injection will help to cure or improve the eye condition.
Outcome measures
| Measure |
Standard Procedure + Culture
n=19 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Proparacaine + Culture
n=17 Participants
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
Proparacaine: Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Conjunctival culture: Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
|---|---|---|
|
Expectation the Injection Will Contribute to Curing/Improving Eye Condition
|
8 score on a scale
Interval 4.0 to 10.0
|
10 score on a scale
Interval 0.0 to 10.0
|
Adverse Events
Standard Procedure + Culture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proparacaine + Culture
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place