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

• ClinicalTrials.gov Identifier: NCT02951351
• Recruitment Status: Completed
• First Posted: November 1, 2016
• Results First Posted: June 25, 2019
• Last Update Posted: June 25, 2019
• Sponsor: Mayo Clinic
• Collaborators: VitreoRetinal Surgery, PA; Research to Prevent Blindness
• Information provided by (Responsible Party): Jose S. Pulido, Mayo Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Age-related Macular Degeneration; Diabetic Macular Edema; Injection Site; Injection Site Infection; Pain, Postoperative	Drug: Proparacaine; Procedure: Conjunctival culture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
• Actual Study Start Date: October 12, 2016
• Actual Primary Completion Date: February 1, 2018
• Actual Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: Conjunctival culture; Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
Experimental: 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.	Drug: Proparacaine; Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.; Other Name: alcaine; Procedure: Conjunctival culture; Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55901

Sponsors and Collaborators

Mayo Clinic

VitreoRetinal Surgery, PA

Research to Prevent Blindness

Investigators

• Principal Investigator: Jose S Pulido, MD; Mayo Clinic

  Study Documents (Full-Text)

Documents provided by Jose S. Pulido, Mayo Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] September 7, 2016

More Information

Additional Information:

Mayo Clinic Clinical Trials 

Publications:

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.

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.

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.

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.

• Responsible Party: Jose S. Pulido, Prinicpal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02951351
• Other Study ID Numbers: 16-004063
• First Posted: November 1, 2016
• Results First Posted: June 25, 2019
• Last Update Posted: June 25, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Macular Degeneration; Macular Edema; Pain, Postoperative; Retinal Degeneration; Retinal Diseases; Eye Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Proxymetacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents