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CompletedNCT04115917DEPRESSUpdated Oct 4, 2019

Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

An interventional study of Schocket scleral depressor and Cotton tipped applicator in Retina--Diseases, Retinal Detachment and Retinal Degeneration, sponsored by New York City Health and Hospitals Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-04.

Sponsored by New York City Health and Hospitals Corporation · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jan 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Retina--Diseases
  • Retinal Detachment
  • Retinal Degeneration

Keywords

  • Scleral Depression
  • Visual Analog Scale
  • Pain
  • Discomfort
  • Schocket Scleral Depressor
  • Cotton Tipped Applicator
  • Diabetes
03

In context

Retinal Detachment

207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.

This study's enrollment of 87 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

New York City Health and Hospitals Corporation is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients who received dilated eye examinations in the retina or general eye clinic

Exclusion criteria

Exclusion Criteria:

  • Younger than 18
  • Pregnant
  • Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Schocket Scleral Depressor

    Scleral Depression with Schocket Scleral Depressor

    Device: Cotton tipped applicator

  • Active comparator
    Cotton Tipped Applicator

    Scleral Depression with Cotton Tipped Applicator

    Device: Schocket scleral depressor

Interventions

  • DeviceSchocket scleral depressor

    Scleral Depression on eye with Schocket scleral depressor

  • DeviceCotton tipped applicator

    Scleral Depression on eye with cotton tipped applicator

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pain evaluated immediately scleral depression was completed on the eye

Secondary outcomes

  1. Hemoglobin A1c

    The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.

    Time frame: 1 year

  2. Spherical Equivalent of Glasses Prescription

    The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.

    Time frame: 1 day

  3. 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

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

  5. Retinal pathology

    Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.

    Time frame: 1 day

07

Study locations

1 site
  • Kings County Hospital
    Brooklyn, New York 11203, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 17, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04115917
Lead sponsor
New York City Health and Hospitals Corporation
Responsible party
Joseph Raevis (Ophthalmologist, New York City Health and Hospitals Corporation) — Principal investigator
First posted
Oct 4, 2019
Start date
Jan 1, 2018
Primary completion
Dec 31, 2018
Completion
Jan 31, 2019
Last update
Oct 4, 2019

Study contacts

Joseph J Raevis, MD
principal investigator · Kings County Hospital Department of Emergency Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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