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Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations (DEPRESS)

Primary Purpose

Retina--Diseases, Retinal Detachment, Retinal Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Schocket scleral depressor
Cotton tipped applicator
Sponsored by
New York City Health and Hospitals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retina--Diseases focused on measuring Scleral Depression, Visual Analog Scale, Pain, Discomfort, Schocket Scleral Depressor, Cotton Tipped Applicator, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kings County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Schocket Scleral Depressor

Cotton Tipped Applicator

Arm Description

Scleral Depression with Schocket Scleral Depressor

Scleral Depression with Cotton Tipped Applicator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hemoglobin A1c
The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.
Spherical Equivalent of Glasses Prescription
The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.
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
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.
Retinal pathology
Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.

Full Information

First Posted
September 21, 2019
Last Updated
October 2, 2019
Sponsor
New York City Health and Hospitals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04115917
Brief Title
Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations
Acronym
DEPRESS
Official Title
Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York City Health and Hospitals Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina--Diseases, Retinal Detachment, Retinal Degeneration
Keywords
Scleral Depression, Visual Analog Scale, Pain, Discomfort, Schocket Scleral Depressor, Cotton Tipped Applicator, Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schocket Scleral Depressor
Arm Type
Experimental
Arm Description
Scleral Depression with Schocket Scleral Depressor
Arm Title
Cotton Tipped Applicator
Arm Type
Active Comparator
Arm Description
Scleral Depression with Cotton Tipped Applicator
Intervention Type
Device
Intervention Name(s)
Schocket scleral depressor
Intervention Description
Scleral Depression on eye with Schocket scleral depressor
Intervention Type
Device
Intervention Name(s)
Cotton tipped applicator
Intervention Description
Scleral Depression on eye with cotton tipped applicator
Primary Outcome Measure Information:
Title
Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator
Description
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 Outcome Measure Information:
Title
Hemoglobin A1c
Description
The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.
Time Frame
1 year
Title
Spherical Equivalent of Glasses Prescription
Description
The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.
Time Frame
1 day
Title
Age
Description
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
Title
Left Eye vs Right Eye
Description
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
Title
Retinal pathology
Description
Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients who received dilated eye examinations in the retina or general eye clinic Exclusion Criteria: Younger than 18 Pregnant Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Raevis, MD
Organizational Affiliation
Kings County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

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