Time Efficiency Comparison of Two IntraVitreal Injection Techniques
TIVI
1 other identifier
interventional
200
1 country
1
Brief Summary
Prospective, single-center, randomized, clinical trial (RCT) comparing the time efficiency and safety of a single-use intravitreal injection (IVI) guide versus a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Start
First participant enrolled
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2021
CompletedApril 27, 2021
April 1, 2021
2 months
June 28, 2020
April 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of intravitreal injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
At time of injection procedure
Secondary Outcomes (2)
Adverse event rate
Immediately and up to 1 month after the intravitreal injection procedure
Patient preference for IVI technique
Immediately post injection using single-blade speculum
Study Arms (2)
Intravitreal injection guide
OTHERSingle use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye
Dual blade eyelid speculum
OTHERDual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
Interventions
A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion
A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.
Eligibility Criteria
You may qualify if:
- \* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
You may not qualify if:
- History of extraocular or intraocular infection within 3 months of the scheduled IVI date
- Scleral thinning
- History of previous glaucoma surgery
- History of pars plana vitrectomy
- Hypersensitivity to the IVI drug, proparacaine or povidone iodine
- Inability to understand the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peregrine Eye and Laser Instittute
Makati City, MM, 1209, Philippines
Related Publications (1)
Uy HS, Artiaga JCM. Comparison of Two Different Intravitreal Injection Techniques. Clin Ophthalmol. 2021 Jun 8;15:2383-2389. doi: 10.2147/OPTH.S309501. eCollection 2021.
PMID: 34135566DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harvey S Uy, MD
Peregrine Eye and Laser Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
June 28, 2020
First Posted
July 2, 2020
Study Start
November 9, 2020
Primary Completion
January 9, 2021
Study Completion
January 9, 2021
Last Updated
April 27, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share