NCT04455399|Completed
Time Efficiency Comparison of Two IntraVitreal Injection Techniques
TIVI
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TIVI
Sponsor study identifier
interventional
200
1 country
1
Study Start
November 9, 2020
Actual (reported)Primary Completion
January 9, 2021
Actual (reported)Study Completion
January 9, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 9, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2020
Actual (reported)July 2, 2020
Actual (reported)November 9, 2020
Actual (reported)January 9, 2021
Actual (reported)January 9, 2021
Actual (reported)Duration of intravitreal injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
At time of injection procedure
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
Single 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 to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
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
Peregrine Eye and Laser Instittute
Makati City, MM, 1209, Philippines
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.
Harvey S Uy, MD
Peregrine Eye and Laser Institute
200 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2020
First Posted
July 2, 2020
Study Start
November 9, 2020
Actual (reported)Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 9, 2021
Actual (reported)Study Completion
January 9, 2021
Actual (reported)Last Updated
April 27, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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