Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

Study Overview
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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.

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

Conditions
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Intravitreal Injection, Pain

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eyelid Speculum<br>Eyelid retraction was performed with an eyelid speculum. | Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.<br>* 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.<br>|
| Experimental: Cotton Tipped Applicator<br>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.<br>* 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.<br>|
| Experimental: Unimanual Eyelid Retraction<br>Eyelid retraction was performed with the unimanual eyelid retraction method. | Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discomfort, Visual Analog Scale, Speculum, Eyelid retraction, Cotton tipped applicator, Eyelid Speculum, Unimanual eyelid retraction