Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques

NCT04144985 | Completed

• 1 other identifier: JJR223
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravitreal Injection; Pain

Keywords

Discomfort; Visual Analog Scale; Speculum; Eyelid retraction; Cotton tipped applicator; Eyelid Speculum; Unimanual eyelid retraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in Pain in Treatment Naive Participants

  1 minute

• Associations of Hemoglobin A1c and Ocular Pain

  1 minute

Study Arms (3)

Eyelid Speculum

ACTIVE COMPARATOR

Eyelid retraction was performed with an eyelid speculum.

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

Cotton Tipped Applicator

EXPERIMENTAL

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.

Unimanual Eyelid Retraction

EXPERIMENTAL

Eyelid retraction was performed with the unimanual eyelid retraction method.

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

Interventions

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.

Cotton Tipped Applicator; Eyelid Speculum; Unimanual Eyelid Retraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants receiving an intravitreal injection

You may not qualify if:

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

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph J Raevis, MD

  Kings County Hospital Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Ophthalmology Resident

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 30, 2019
• Study Start: October 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)