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Completed

NCT Number: NCT04144985

Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

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.

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Key information

Conditions

Intravitreal Injection Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kings County Hospital

Brooklyn, New York, 11203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants receiving an intravitreal injection

Exclusion criteria

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

Treatment and study plan

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

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.

Primary outcomes

  1. Pain Associated with Different Eyelid Retraction Technique

    Time frame: 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 outcomes

  1. Difference in Pain in Treatment Naive Participants

    Time frame: 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.

  2. Associations of Hemoglobin A1c and Ocular Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York City Health and Hospitals Corporation

Other

Registry information

Official study title

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

Acronym: Eyelid RETRACT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2019
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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