DEPRESS: Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

Sponsor

New York City Health and Hospitals Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT04115917

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retina--Diseases Retinal Detachment Retinal Degeneration	Device: Schocket scleral depressor Device: Cotton tipped applicator	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator [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.

Secondary Outcome Measures

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