Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

Retinal Detachment Clinical Trial

— DEPRESS  

Official title:

Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115917
• Other study ID #: JJR666
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2019
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Retina--Diseases
• Retinal Degeneration
• Retinal Detachment

Intervention

Device:
• Schocket scleral depressor
Scleral Depression on eye with Schocket scleral depressor
• Cotton tipped applicator
Scleral Depression on eye with cotton tipped applicator

Locations

Country	Name	City	State
United States	Kings County Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pain evaluated immediately scleral depression was completed on the eye
Secondary	Hemoglobin A1c	The association of discomfort experienced during scleral depression and the patients hemoglobin A1c.	1 year
Secondary	Spherical Equivalent of Glasses Prescription	The association of discomfort experienced during scleral depression and the patients spherical equivalent of their glasses prescription.	1 day
Secondary	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	1 day
Secondary	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.	1 day
Secondary	Retinal pathology	Discomfort during scleral depression in participants with peripheral retinal tears or holes versus patients with no peripheral retinal pathology.	1 day