Clinical trial NCT02951351: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Diabetic Macular Edema
Injection Site
Injection Site Infection
Pain, Postoperative
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: VitreoRetinal Surgery, PA
name: Research to Prevent Blindness
First posted: 2016-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of Study Participants With Positive Conjunctival Culture
timeFrame: pre-injection
measure: Pain at the Time of Injection
timeFrame: post-injection
Secondary outcomes:
measure: Residual Pain From Intravitreal Injection
timeFrame: post-injection
measure: Overall Impression of Visit for Intravitreal Injection
timeFrame: post-injection
measure: Impression of Pre-injection Preparations
timeFrame: post-injection
measure: Comfort With Intravitreal Injection Standard Procedure
timeFrame: post-injection
measure: Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health
timeFrame: post-injection
measure: Expectation the Injection Will Contribute to Curing/Improving Eye Condition
timeFrame: post-injection
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jose S Pulido, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.