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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03618875
Other study ID # icepreventpain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date November 25, 2017

Study information

Verified date November 2016
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 25, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

patients receiving intravitreal injection

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel The E.Wolfson Medical Center Holon

Sponsors (1)

Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 size of subconjunctival hemorrhage subconjunctival hemorrhage in mm change between subconjunctival hemorrhage at baseline and 10 minutes
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