Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

NCT ID: NCT04144985

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Intravitreal Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Eyelid Speculum

Eyelid retraction was performed with an eyelid speculum.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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.

Cotton Tipped Applicator

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Unimanual Eyelid Retraction

Eyelid retraction was performed with the unimanual eyelid retraction method.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult participants receiving an intravitreal injection

Exclusion Criteria

* iodine allergy
* prior ocular surgery other than uncomplicated cataract surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York City Health and Hospitals Corporation

OTHER

Sponsor Role lead

Responsible Party

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Joseph Raevis

Chief Ophthalmology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph J Raevis, MD

Role: PRINCIPAL_INVESTIGATOR

Kings County Hospital Department of Emergency Medicine

Locations

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Kings County Hospital

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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JJR223

Identifier Type: -

Identifier Source: org_study_id

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