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OpenTrials
Completed

NCT Number: NCT02951351

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proparacaine

Drug

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

Other names: alcaine

Conjunctival culture

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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..

  4. 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.

  5. 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.

  6. Expectation the Injection Will Contribute to Curing/Improving Eye Condition

    Time frame: post-injection

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Research to Prevent Blindness
  • VitreoRetinal Surgery, PA

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2016
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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