Reduction of Post Intravitreal Injection Bleeding and Pain by Ice

NCT ID: NCT03618875

Last Updated: 2018-08-07

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-11-25

Brief Summary

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Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.

Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

Detailed Description

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cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ice

Patients were randomly assigned to receive an ice 5 minutes prior the IViT

Group Type ACTIVE_COMPARATOR

ice pack

Intervention Type OTHER

ice pack was placed on eyelid 5 minutes prior to IVIT

placebo

Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT

Group Type PLACEBO_COMPARATOR

room temperature pack

Intervention Type OTHER

room temperature pack was placed on eyelid 5 minutes prior to IVIT

Interventions

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ice pack

ice pack was placed on eyelid 5 minutes prior to IVIT

Intervention Type OTHER

room temperature pack

room temperature pack was placed on eyelid 5 minutes prior to IVIT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

patients receiving intravitreal injection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The E.Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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icepreventpain

Identifier Type: -

Identifier Source: org_study_id

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