Intravitreal InjectionEyelid RETRACTNCT04144985
Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques
A study testing Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. in people with Intravitreal Injection and Pain, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intravitreal Injection, Pain
- What is being tested?
- Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants receiving an intravitreal injection
Who cannot join
- iodine allergy
- prior ocular surgery other than uncomplicated cataract surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eyelid Retraction Discomfort With Cotton Tipped Applicator, Unimanual and Speculum Intravitreal Injection Techniques: Eyelid Retraction Technique Randomized Comparison Trial (Eyelid RETRACT)
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.
Read the 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.
- Conditions
- Intravitreal Injection, Pain
- Being tested
- Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.
- Keywords
- Discomfort, Visual Analog Scale, Speculum, Eyelid retraction, Cotton tipped applicator, Eyelid Speculum, Unimanual eyelid retraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Eyelid Speculum | Active comparator | Eyelid retraction was performed with an eyelid speculum. Receives: 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. Receives: 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. Receives: Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Oct 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravitreal InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Raevis, New York City Health and Hospitals Corporation
- Investigators
- Joseph J Raevis, MD, Principal investigator, Kings County Hospital Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144985
- Sponsor's protocol ID
- JJR223
- Acronym
- Eyelid RETRACT
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyelid Retraction Discomfort With Cotton Tipped Applicator, Unimanual and Speculum Intravitreal Injection Techniques: Eyelid Retraction Technique Randomized Comparison Trial (Eyelid RETRACT)
- ClinicalTrials.gov ID
- NCT04144985
- Acronym / sponsor ID
- Eyelid RETRACT / JJR223
- Conditions
- Intravitreal Injection, Pain
- Keywords
- Discomfort, Visual Analog Scale, Speculum, Eyelid retraction, Cotton tipped applicator, Eyelid Speculum, Unimanual eyelid retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eyelid Speculum | Active comparator | Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.Eyelid retraction was performed with an eyelid speculum. |
| Cotton Tipped Applicator | Experimental | Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.Eyelid retraction was performed with the cotton tipped applicator eyelid retraction technique. |
| Unimanual Eyelid Retraction | Experimental | Other: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.Eyelid retraction was performed with the unimanual eyelid retraction method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult participants receiving an intravitreal injection
Key exclusion criteria (2 listed)
- iodine allergy
- prior ocular surgery other than uncomplicated cataract surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cotton Tipped Applicator, Eyelid Speculum, Unimanual Eyelid Retraction |
Primary outcome
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.
2 secondary outcomes
Difference in Pain in Treatment Naive Participants
Time frame: 1 minute
Associations of Hemoglobin A1c and Ocular Pain
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J Raevis, MD principal investigator
Kings County Hospital Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. in people with Intravitreal Injection and Pain, run by New York City Health and Hospitals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Associated with Different Eyelid Retraction Technique (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.