Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

NCT ID: NCT04115917

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Retina--Diseases Retinal Detachment Retinal Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Schocket Scleral Depressor

Scleral Depression with Schocket Scleral Depressor

Group Type EXPERIMENTAL

Cotton tipped applicator

Intervention Type DEVICE

Scleral Depression on eye with cotton tipped applicator

Cotton Tipped Applicator

Scleral Depression with Cotton Tipped Applicator

Group Type ACTIVE_COMPARATOR

Schocket scleral depressor

Intervention Type DEVICE

Scleral Depression on eye with Schocket scleral depressor

Interventions

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Schocket scleral depressor

Scleral Depression on eye with Schocket scleral depressor

Intervention Type DEVICE

Cotton tipped applicator

Scleral Depression on eye with cotton tipped applicator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York City Health and Hospitals Corporation

OTHER

Sponsor Role lead

Responsible Party

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Joseph Raevis

Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph J Raevis, MD

Role: PRINCIPAL_INVESTIGATOR

Kings County Hospital Department of Emergency Medicine

Locations

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Kings County Hospital

Brooklyn, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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JJR666

Identifier Type: -

Identifier Source: org_study_id

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