Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

Not Applicable

Completed

• Conditions: Pain; Intravitreal Injection
• Interventions: Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.

• Registration Number: NCT04144985
• Lead Sponsor: New York City Health and Hospitals Corporation

Brief Summary

This study evaluated the discomfort associated with eyelid retraction during intravitreal injections. Participants had eyelid retraction with one of three methods: eyelid speculum, unimanual eyelid retraction method or with a cotton tipped applicator eyelid retraction technique. All participants were given a pain survey immediately after the injection to evaluate their discomfort level.

Detailed Description

Comfort is an important factor in compliance and satisfaction during medical care With the millions of intravitreal injections done each year, even small improvements in participants' experiences could lead to significant benefit. During the process eye injections, the method of eyelid retraction has been shown to be one of the most significant sources of discomfort.

Many ophthalmologists use an eyelid speculum to retract the eyelids, but potentially more comfortable methods exist. The purpose of our study was to test the comfort eyelid retraction with an eyelid speculum to that of the unimanual eyelid retraction method and a cotton tipped applicator eyelid retraction technique.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Adult participants receiving an intravitreal injection

Exclusion Criteria

• iodine allergy
• prior ocular surgery other than uncomplicated cataract surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eyelid Speculum	Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.	Eyelid retraction was performed with an eyelid speculum.
Unimanual Eyelid Retraction	Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.	Eyelid retraction was performed with the unimanual eyelid retraction method.
Cotton Tipped Applicator	Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.	Eyelid retraction was performed with the cotton tipped applicator eyelid retraction technique.

Primary Outcome Measures

Name	Time	Method
Pain Associated with Different Eyelid Retraction Technique	1 minute	Within one minute of the injection, the participant was given a standard 100mm long visual analog scale (VAS) and asked to rate their pain from 0mm (no pain) to 100mm (the worst pain) regarding the process of the intravitreal injection.

Secondary Outcome Measures

Name	Time	Method
Difference in Pain in Treatment Naive Participants	1 minute	Visual analog scale (VAS) of pain was compared between participant that had prior intravitreal injections and those that were treatment naive. Within one minute of the injection, the participant was given a standard 100mm long visual analog scale (VAS) and asked to rate their pain from 0mm (no pain) to 100mm (the worst pain) regarding the process of the intravitreal injection.
Associations of Hemoglobin A1c and Ocular Pain	1 minute	Visual analog scale (VAS) of pain was compared to participants with different hemoglobin A1c level. Within one minute of the injection, the participant was given a standard 100mm long visual analog scale (VAS) and asked to rate their pain from 0mm (no pain) to 100mm (the worst pain) regarding the process of the intravitreal injection.

Trial Locations

Locations (1)

Kings County Hospital; 🇺🇸 Brooklyn, New York, United States