Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations

NCT04115917 | Completed

• 1 other identifier: JJR666
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Retina--Diseases; Retinal Detachment; Retinal Degeneration

Keywords

Scleral Depression; Visual Analog Scale; Pain; Discomfort; Schocket Scleral Depressor; Cotton Tipped Applicator; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hemoglobin A1c

  1 year

• Spherical Equivalent of Glasses Prescription

  1 day

• Age

  1 day

• Left Eye vs Right Eye

  1 day

• Retinal pathology

  1 day

Study Arms (2)

Schocket Scleral Depressor

EXPERIMENTAL

Scleral Depression with Schocket Scleral Depressor

Device: Cotton tipped applicator

Cotton Tipped Applicator

ACTIVE COMPARATOR

Scleral Depression with Cotton Tipped Applicator

Device: Schocket scleral depressor

Interventions

Schocket scleral depressor DEVICE

Scleral Depression on eye with Schocket scleral depressor

Cotton Tipped Applicator

Cotton tipped applicator DEVICE

Scleral Depression on eye with cotton tipped applicator

Schocket Scleral Depressor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who received dilated eye examinations in the retina or general eye clinic

You may not qualify if:

• Younger than 18
• Pregnant
• Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Retinal Detachment; Retinal Degeneration; Pain; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joseph J Raevis, MD

  Kings County Hospital Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: October 4, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)