Topical Ice-therapy for Intravitreal Injections

NCT ID: NCT05269823

Last Updated: 2025-08-22

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-04-30

Brief Summary

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Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.

Detailed Description

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Conditions

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Anesthesia; Hypothermia Injection Site Irritation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ice-therapy

Ice therapy will be provided prior to the provision of the intravitreal injection

Group Type ACTIVE_COMPARATOR

Ice-therapy

Intervention Type OTHER

Ice therapy will be provided prior to intravitreal injection provision

No Ice-therapy

No ice therapy will be provided prior to the provision of the intravitreal injection

Group Type PLACEBO_COMPARATOR

No Ice-therapy

Intervention Type OTHER

No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision

Interventions

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Ice-therapy

Ice therapy will be provided prior to intravitreal injection provision

Intervention Type OTHER

No Ice-therapy

No additional intervention (i.e.) ice therapy will be provided prior to intravitreal injection provision

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jade Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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OPH-2022-30605

Identifier Type: -

Identifier Source: org_study_id

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