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

October 2, 2019 updated by: Joseph Raevis, New York City Health and Hospitals Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Schocket Scleral Depressor
Scleral Depression with Schocket Scleral Depressor
Device: Cotton tipped applicator
Scleral Depression on eye with cotton tipped applicator
Active Comparator: Cotton Tipped Applicator
Scleral Depression with Cotton Tipped Applicator
Device: Schocket scleral depressor
Scleral Depression on eye with Schocket scleral depressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain evaluated immediately scleral depression was completed on the eye

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 1 year
The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.
1 year
Spherical Equivalent of Glasses Prescription
Time Frame: 1 day
The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.
1 day
Age
Time Frame: 1 day
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
1 day
Left Eye vs Right Eye
Time Frame: 1 day
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.
1 day
Retinal pathology
Time Frame: 1 day
Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York City Health and Hospitals Corporation

Investigators

  • Principal Investigator: Joseph J Raevis, MD, Kings County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

September 21, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJR666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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