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

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Mayo Clinic

Status

Completed

Conditions

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

Treatments

Procedure: Conjunctival culture
Drug: Proparacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02951351
16-004063

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Standard procedure + Culture
Active Comparator group
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.
Treatment:
Procedure: Conjunctival culture
Proparacaine + Culture
Experimental group
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.
Treatment:
Drug: Proparacaine
Procedure: Conjunctival culture

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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