- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951351
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
April 11, 2023 updated by: Mayo Clinic
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55901
- Mayo Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 cultures will be performed to ensure that the intervention does not interfere with antisepsis.
|
Experimental: 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.
|
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Study Participants With Positive Conjunctival Culture
Time Frame: 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.
|
pre-injection
|
Pain at the Time of Injection
Time Frame: 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.
|
post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual Pain From Intravitreal Injection
Time Frame: 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.
|
post-injection
|
Overall Impression of Visit for Intravitreal Injection
Time Frame: 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.
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post-injection
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Impression of Pre-injection Preparations
Time Frame: 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..
|
post-injection
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Comfort With Intravitreal Injection Standard Procedure
Time Frame: 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.
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post-injection
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Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
Time Frame: 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.
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post-injection
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Expectation the Injection Will Contribute to Curing/Improving Eye Condition
Time Frame: post-injection
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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.
|
post-injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jose S Pulido, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2016
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
October 29, 2016
First Submitted That Met QC Criteria
October 31, 2016
First Posted (Estimate)
November 1, 2016
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Retinal Degeneration
- Retinal Diseases
- Pain, Postoperative
- Macular Degeneration
- Macular Edema
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Proxymetacaine
Other Study ID Numbers
- 16-004063
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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