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Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

Primary Purpose

Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proparacaine
Conjunctival culture
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard procedure + Culture

Proparacaine + Culture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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..
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.
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.
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.

Full Information

First Posted
October 29, 2016
Last Updated
April 11, 2023
Sponsor
Mayo Clinic
Collaborators
VitreoRetinal Surgery, PA, Research to Prevent Blindness
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1. Study Identification

Unique Protocol Identification Number
NCT02951351
Brief Title
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
Official Title
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
VitreoRetinal Surgery, PA, Research to Prevent Blindness

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Diabetic Macular Edema, Injection Site, Injection Site Infection, Pain, Postoperative

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard procedure + Culture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Proparacaine + Culture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Proparacaine
Other Intervention Name(s)
alcaine
Intervention Description
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Intervention Type
Procedure
Intervention Name(s)
Conjunctival culture
Intervention Description
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
Primary Outcome Measure Information:
Title
Number of Study Participants With Positive Conjunctival Culture
Description
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
Title
Pain at the Time of Injection
Description
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
Secondary Outcome Measure Information:
Title
Residual Pain From Intravitreal Injection
Description
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
Title
Overall Impression of Visit for Intravitreal Injection
Description
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
Title
Impression of Pre-injection Preparations
Description
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
Title
Comfort With Intravitreal Injection Standard Procedure
Description
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
Title
Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
Description
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
Title
Expectation the Injection Will Contribute to Curing/Improving Eye Condition
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose S Pulido, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2994609
Citation
Isenberg SJ, Apt L, Yoshimori R, Khwarg S. Chemical preparation of the eye in ophthalmic surgery. IV. Comparison of povidone-iodine on the conjunctiva with a prophylactic antibiotic. Arch Ophthalmol. 1985 Sep;103(9):1340-2. doi: 10.1001/archopht.1985.01050090092039.
Results Reference
background
PubMed Identifier
6721765
Citation
Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
Results Reference
background
PubMed Identifier
11196120
Citation
Oguz H, Oguz E, Karadede S, Aslan G. The antibacterial effect of topical anesthetic proparacaine on conjunctival flora. Int Ophthalmol. 1999;23(2):117-20. doi: 10.1023/a:1026567912389.
Results Reference
background
PubMed Identifier
25901838
Citation
van Asten F, van Middendorp H, Verkerk S, Breukink MB, Lomme RM, Hoyng CB, Evers AW, Klevering BJ. ARE INTRAVITREAL INJECTIONS WITH ULTRATHIN 33-G NEEDLES LESS PAINFUL THAN THE COMMONLY USED 30-G NEEDLES? Retina. 2015 Sep;35(9):1778-85. doi: 10.1097/IAE.0000000000000550.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

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