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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951351
• Other study ID #: 16-004063
• Status: Completed
• Phase: N/A
• Start date: October 12, 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Injection Site
• Injection Site Infection
• Macular Degeneration
• Macular Edema
• Pain, Postoperative

Intervention

Drug:
• Proparacaine
Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.

Procedure:
• Conjunctival culture
Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Research to Prevent Blindness, VitreoRetinal Surgery, PA

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	pre-injection
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.	post-injection
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.	post-injection
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.	post-injection
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..	post-injection
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.	post-injection
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.	post-injection
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.	post-injection

External Links

•   Mayo Clinic Clinical Trials