Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site, Injection Site Infection, Pain, Postoperative
Conditions
Brief summary
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
Detailed description
To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.
Interventions
DRUGProparacaine
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
PROCEDUREConjunctival culture
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
Sponsors
VitreoRetinal Surgery, PA
Research to Prevent Blindness
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing intravitreal injection who do not have active eye infections * greater than 18 years of age
Exclusion criteria
* patients younger than 18 years of age * patients with active eye infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants With Positive Conjunctival Culture | pre-injection | 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. |
| Pain at the Time of Injection | post-injection | Subjects 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impression of Pre-injection Preparations | post-injection | Subjects 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.. |
| Comfort With Intravitreal Injection Standard Procedure | post-injection | Subjects 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. |
| Residual Pain From Intravitreal Injection | post-injection | Subjects 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. |
| Expectation the Injection Will Contribute to Curing/Improving Eye Condition | post-injection | Patients 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. |
| Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health | post-injection | Subjects 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. |
| Overall Impression of Visit for Intravitreal Injection | post-injection | Subjects 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 17 |
| Total | 36 |
Baseline characteristics
| Characteristic | Standard Procedure + Culture | Proparacaine + Culture | Total |
|---|---|---|---|
| Age, Continuous | 78.1 years | 73.2 years | 77.3 years |
| Injection drug administered Aflibercept | 3 Participants | 7 Participants | 10 Participants |
| Injection drug administered Bevacizumab | 16 Participants | 10 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 19 participants | 17 participants | 36 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
Primary
Number of Study Participants With Positive Conjunctival Culture
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.
Time frame: pre-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Procedure + Culture | Number of Study Participants With Positive Conjunctival Culture | 1 Participants |
| Proparacaine + Culture | Number of Study Participants With Positive Conjunctival Culture | 1 Participants |
p-value: 0.28Wilcoxon (Mann-Whitney)
Primary
Pain at the Time of Injection
Subjects 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Pain at the Time of Injection | 2 score on a scale |
| Proparacaine + Culture | Pain at the Time of Injection | 1 score on a scale |
p-value: 0.25Wilcoxon (Mann-Whitney)
Secondary
Comfort With Intravitreal Injection Standard Procedure
Subjects 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Comfort With Intravitreal Injection Standard Procedure | 0 score on a scale |
| Proparacaine + Culture | Comfort With Intravitreal Injection Standard Procedure | 0 score on a scale |
p-value: 0.31Wilcoxon (Mann-Whitney)
Secondary
Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
Subjects 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health | 0 score on a scale |
| Proparacaine + Culture | Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health | 0 score on a scale |
p-value: 0.18Wilcoxon (Mann-Whitney)
Secondary
Expectation the Injection Will Contribute to Curing/Improving Eye Condition
Patients 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Expectation the Injection Will Contribute to Curing/Improving Eye Condition | 8 score on a scale |
| Proparacaine + Culture | Expectation the Injection Will Contribute to Curing/Improving Eye Condition | 10 score on a scale |
p-value: 0.67Wilcoxon (Mann-Whitney)
Secondary
Impression of Pre-injection Preparations
Subjects 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..
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Impression of Pre-injection Preparations | 0 score on a scale |
| Proparacaine + Culture | Impression of Pre-injection Preparations | 0 score on a scale |
p-value: 0.76Wilcoxon (Mann-Whitney)
Secondary
Overall Impression of Visit for Intravitreal Injection
Subjects 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Overall Impression of Visit for Intravitreal Injection | 0 score on a scale |
| Proparacaine + Culture | Overall Impression of Visit for Intravitreal Injection | 0 score on a scale |
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
Residual Pain From Intravitreal Injection
Subjects 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.
Time frame: post-injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Procedure + Culture | Residual Pain From Intravitreal Injection | 1 score on a scale |
| Proparacaine + Culture | Residual Pain From Intravitreal Injection | 0 score on a scale |
p-value: 0.86Wilcoxon (Mann-Whitney)