Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

Pain Clinical Trial

— Eyelid RETRACT  

Official title:

Eyelid Retraction Discomfort With Cotton Tipped Applicator, Unimanual and Speculum Intravitreal Injection Techniques: Eyelid Retraction Technique Randomized Comparison Trial (Eyelid RETRACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144985
• Other study ID #: JJR223
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: October 2019
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants receiving an intravitreal injection

Exclusion Criteria:

• iodine allergy

• prior ocular surgery other than uncomplicated cataract surgery

Related Conditions & MeSH terms

• Intravitreal Injection
• Pain

Intervention

Other:
• Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.
Eyelid retraction was performed with one of the three methods (eyelid speculum, unimanual eyelid retraction or cotton tipped applicator assisted eyelid retraction) and participants were then asked to rate their discomfort during the procedure with a visual analog scale (VAS) of pain.

Locations

Country	Name	City	State
United States	Kings County Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Associated with Different Eyelid Retraction Technique	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.	1 minute
Secondary	Difference in Pain in Treatment Naive Participants	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.	1 minute
Secondary	Associations of Hemoglobin A1c and Ocular Pain	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.	1 minute