NCT03618875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 26, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

November 26, 2017

Last Update Submit

August 5, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • pain

    Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort

    change between VAS pain score at baseline and 10 minutes

Secondary Outcomes (1)

  • size of subconjunctival hemorrhage

    change between subconjunctival hemorrhage at baseline and 10 minutes

Study Arms (2)

ice

ACTIVE COMPARATOR

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

Other: ice pack

placebo

PLACEBO COMPARATOR

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

Other: room temperature pack

Interventions

ice packOTHER

ice pack was placed on eyelid 5 minutes prior to IVIT

ice
room temperature packOTHER

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

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving intravitreal injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The E.Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2017

First Posted

August 7, 2018

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 25, 2017

Last Updated

August 7, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

no plan

Locations

IL(1)