Retina--DiseasesDEPRESSNCT04115917
Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations
A study testing Schocket scleral depressor and Cotton tipped applicator in people with Retina--Diseases and Retinal Detachment, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
Scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. The goal of this study was to compare levels of discomfort during scleral depression with a Schocket scleral depressor and cotton tipped applicator. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retina--Diseases, Retinal Detachment, Retinal Degeneration
- What is being tested?
- Schocket scleral depressor and Cotton tipped applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Jan 2019
- 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 patients who received dilated eye examinations in the retina or general eye clinic
Who cannot join
- Younger than 18
- Pregnant
- Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)
Scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. The goal of this study was to compare levels of discomfort during scleral depression with a Schocket scleral depressor and cotton tipped applicator.
- Conditions
- Retina--Diseases, Retinal Detachment, Retinal Degeneration
- Being tested
- Schocket scleral depressor, Cotton tipped applicator
- Keywords
- Scleral Depression, Visual Analog Scale, Pain, Discomfort, Schocket Scleral Depressor, Cotton Tipped Applicator, Diabetes
- Medical subject headings
- Retinal Detachment, Retinal Degeneration, Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schocket scleral depressorDevice
Scleral Depression on eye with Schocket scleral depressor
Cotton tipped applicatorDevice
Scleral Depression on eye with cotton tipped applicator
| Study group | Role | What they receive |
|---|---|---|
| Schocket Scleral Depressor | Experimental | Scleral Depression with Schocket Scleral Depressor Receives: Device: Cotton tipped applicator |
| Cotton Tipped Applicator | Active comparator | Scleral Depression with Cotton Tipped Applicator Receives: Device: Schocket scleral depressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator
Visual Analog Scale (VAS) was used to evaluate pain immediately after scleral depression was completed. The VAS scale used was a 100mm long line with 0 representing no pain at all and 100 representing the worst pain possible.
Measured: Pain evaluated immediately scleral depression was completed on the eye
Secondary outcomes (5)
Hemoglobin A1c
The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.
Measured: 1 year
Spherical Equivalent of Glasses Prescription
The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.
Measured: 1 day
Age
The association of discomfort experienced during scleral depression and the patients age based on those less than 65 versus those greater than 65 years of age
Measured: 1 day
Left Eye vs Right Eye
The association of discomfort experienced during scleral depression and the patients left and right eyes. Of note, each eye had a separate method of scleral depression performed.
Measured: 1 day
Retinal pathology
Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina--DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The first eye to undergo scleral depression was randomly assigned, then that eye was randomized two either of the scleral depression methods. The contralateral eye then had the alternative method of scleral depression performed.
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT04115917
- Sponsor's protocol ID
- JJR666
- Acronym
- DEPRESS
- Status last verified
- Oct 2019
- First submitted
- 21 Sep 2019
- Last updated
- 4 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)
- ClinicalTrials.gov ID
- NCT04115917
- Acronym / sponsor ID
- DEPRESS / JJR666
- Conditions
- Retina--Diseases, Retinal Detachment, Retinal Degeneration
- Keywords
- Scleral Depression, Visual Analog Scale, Pain, Discomfort, Schocket Scleral Depressor, Cotton Tipped Applicator, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 4 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.
Scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. The goal of this study was to compare levels of discomfort during scleral depression with a Schocket scleral depressor and cotton tipped applicator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first eye to undergo scleral depression was randomly assigned, then that eye was randomized two either of the scleral depression methods. The contralateral eye then had the alternative method of scleral depression performed.
| Arm | Type | Receives |
|---|---|---|
| Schocket Scleral Depressor | Experimental | Device: Cotton tipped applicatorScleral Depression with Schocket Scleral Depressor |
| Cotton Tipped Applicator | Active comparator | Device: Schocket scleral depressorScleral Depression with Cotton Tipped Applicator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who received dilated eye examinations in the retina or general eye clinic
Key exclusion criteria (3 listed)
- Younger than 18
- Pregnant
- Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month
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 |
|---|---|---|
| Schocket scleral depressorScleral Depression on eye with Schocket scleral depressor | Device | Cotton Tipped Applicator |
| Cotton tipped applicatorScleral Depression on eye with cotton tipped applicator | Device | Schocket Scleral Depressor |
Primary outcome
Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator
Time frame: Pain evaluated immediately scleral depression was completed on the eye
Visual Analog Scale (VAS) was used to evaluate pain immediately after scleral depression was completed. The VAS scale used was a 100mm long line with 0 representing no pain at all and 100 representing the worst pain possible.
5 secondary outcomes
Hemoglobin A1c
Time frame: 1 year
Spherical Equivalent of Glasses Prescription
Time frame: 1 day
Age
Time frame: 1 day
Left Eye vs Right Eye
Time frame: 1 day
Retinal pathology
Time frame: 1 day
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 4 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 Schocket scleral depressor and Cotton tipped applicator in people with Retina--Diseases and Retinal Detachment, 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 3 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 4 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?
Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator (time frame: Pain evaluated immediately scleral depression was completed on the eye). 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 4 Oct 2019.