NCT02497092

Brief Summary

The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

July 7, 2015

Last Update Submit

April 17, 2016

Conditions

Injection Site Discomfort

Outcome Measures

Primary Outcomes (1)

  • Pain during the injection as measured by the "Pain numeric rating scale"

    Up to 2 minutes after the injection

Study Arms (4)

Slow angled injection

ACTIVE COMPARATOR

Slow and angled insertion of the needle through the sclera

Other: Technique of injection

Slow straight injection

ACTIVE COMPARATOR

Slow and straight insertion of the needle through the sclera

Other: Technique of injection

Fast angled injection

ACTIVE COMPARATOR

fast and angled insertion of the needle through the sclera

Other: Technique of injection

Fast straight injection

ACTIVE COMPARATOR

fast and straight insertion of the needle through the sclera

Other: Technique of injection

Interventions

Technique of injectionOTHER
Fast angled injectionFast straight injectionSlow angled injectionSlow straight injection

Eligibility Criteria

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

You may qualify if:

  • Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections
  • Informed consent

You may not qualify if:

  • Dementia or any other reason for cognitive deterioration
  • Technical limitations not allowing injecting by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Study Officials

  • Amir Sternfeld, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Sternfeld, MD

CONTACT

972-50-7665980shtery@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

IL(1)