Eyelid RETRACT: Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

Sponsor

New York City Health and Hospitals Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT04144985

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intravitreal Injection Pain	Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Mar 31, 2018

Actual Study Completion Date :

Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Eyelid Speculum Eyelid retraction was performed with an eyelid speculum.	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.
Experimental: Cotton Tipped Applicator Eyelid retraction was performed with the cotton tipped applicator eyelid retraction technique.	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.
Experimental: Unimanual Eyelid Retraction Eyelid retraction was performed with the unimanual eyelid retraction method.	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.

Arm

Intervention/Treatment

Active Comparator: Eyelid Speculum

Eyelid retraction was performed with an eyelid speculum.

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.

Experimental: Cotton Tipped Applicator

Eyelid retraction was performed with the cotton tipped applicator eyelid retraction technique.

Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.

Experimental: Unimanual Eyelid Retraction

Eyelid retraction was performed with the unimanual eyelid retraction method.

Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult participants receiving an intravitreal injection

Exclusion Criteria:

iodine allergy
prior ocular surgery other than uncomplicated cataract surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kings County Hospital	Brooklyn	New York	United States	11203

Sponsors and Collaborators

New York City Health and Hospitals Corporation

Investigators

Principal Investigator: Joseph J Raevis, MD, Kings County Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Raevis, Chief Ophthalmology Resident, New York City Health and Hospitals Corporation

ClinicalTrials.gov Identifier:

NCT04144985

Other Study ID Numbers:

JJR223

First Posted:

Oct 30, 2019

Last Update Posted:

Oct 30, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joseph Raevis, Chief Ophthalmology Resident, New York City Health and Hospitals Corporation

Cotton tipped applicator

Eyelid Speculum

Unimanual eyelid retraction

Study Results

No Results Posted as of Oct 30, 2019