Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

Not Applicable

Completed

• Conditions: Retinal Degeneration; Retinal Detachment; Retina--Diseases
• Interventions: Device: Schocket scleral depressor; Device: Cotton tipped applicator

• Registration Number: NCT04115917
• Lead Sponsor: New York City Health and Hospitals Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Study First Submitted: 2019-09-21
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cotton Tipped Applicator	Schocket scleral depressor	Scleral Depression with Cotton Tipped Applicator
Schocket Scleral Depressor	Cotton tipped applicator	Scleral Depression with Schocket Scleral Depressor

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Kings County Hospital; 🇺🇸 Brooklyn, New York, United States