Retinal DiseasesNCT02196584
Clinical Evaluation of the RAVI-Guide
An observational study of Retinal Diseases, run by Medical College of Wisconsin at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Diseases
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years of age or older who undergo intravitreal injection
Who may be able to join
- Patients age 18 years or older who undergo intravitreal injection for clinical indications.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert and Medical College of Wisconsin Eye Institute
Milwaukee, Wisconsin, 53226
About this study
Official title: Clinical Evaluation of the Rapid Access Vitreal Injection Guide (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
- Conditions
- Retinal Diseases
- Medical subject headings
- Retinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 15 minutes of injection procedure
Secondary outcomes (1)
Procedural complications associated with instrument use during intravitreal injection procedure
A questionnaire that queries about procedural complications will be completed by the treating physician.
Measured: Within 15 minutes of injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Han, Medical College of Wisconsin
- Investigators
- Dennis P Han, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196584
- Sponsor's protocol ID
- PRO00021075
- Status last verified
- Jun 2016
- First submitted
- 19 Jul 2014
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)
- ClinicalTrials.gov ID
- NCT02196584
- Acronym / sponsor ID
- PRO00021075
- Conditions
- Retinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older who undergo intravitreal injection
Key inclusion criteria (1 listed)
- Patients age 18 years or older who undergo intravitreal injection for clinical indications.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Procedural complications associated with instrument use during intravitreal injection procedure
Time frame: Within 15 minutes of injection procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis P Han, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Diseases, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity associated with instrument type used for holding eyelids open during intravitreal injection (time frame: Within 15 minutes of injection procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.