NCT02196584

Brief Summary

Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

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

First Submitted

Initial submission to the registry

July 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

July 19, 2014

Last Update Submit

June 22, 2016

Conditions

Retinal Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain severity associated with instrument type used for holding eyelids open during intravitreal injection

    A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity.

    Within 15 minutes of injection procedure

Secondary Outcomes (1)

  • Procedural complications associated with instrument use during intravitreal injection procedure

    Within 15 minutes of injection procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients 18 years of age or older who undergo intravitreal injection

You may qualify if:

  • Patients age 18 years or older who undergo intravitreal injection for clinical indications.

You may not qualify if:

  • Patients under the age of 18 years
  • Patients unable to give informed consent
  • Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection
  • Disorders that preclude the ability to assess for complications of intravitreal injection
  • Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus
  • Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert and Medical College of Wisconsin Eye Institute

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Dennis P Han, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

July 19, 2014

First Posted

July 22, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

US(1)