Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
NCT ID: NCT02951351
Last Updated: 2023-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2016-10-12
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* greater than 18 years of age
Exclusion Criteria
* patients with active eye infections
18 Years
ALL
Yes
Sponsors
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VitreoRetinal Surgery, PA
OTHER
Research to Prevent Blindness
OTHER
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Jose S Pulido, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-004063
Identifier Type: -
Identifier Source: org_study_id
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