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OpenTrials
Completed

NCT Number: NCT02196584

Clinical Evaluation of the RAVI-Guide

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

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Key information

Conditions

Retinal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert and Medical College of Wisconsin Eye Institute

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: Within 15 minutes of injection procedure

    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.

Secondary outcomes

  1. Procedural complications associated with instrument use during intravitreal injection procedure

    Time frame: Within 15 minutes of injection procedure

    A questionnaire that queries about procedural complications will be completed by the treating physician.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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