Time Efficiency Comparison of Two IntraVitreal Injection Techniques

Diabetic Macular Edema Clinical Trial

— TIVI  

Official title:

Time Efficiency Comparison of Two Intravitreal Injection Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455399
• Other study ID #: 20200102
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: January 9, 2021

Study information

• Verified date: April 2021
• Source: Peregrine Eye and Laser Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.

The investigators will include eyes of adult patients scheduled to undergo unilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a 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, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.

The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 9, 2021
• Est. primary completion date: January 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Eyes of adult patients requiring intravitreally injected medications for non-infectious indications

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Neovascularization, Pathologic
• Retinal Vein Occlusion
• Retinal Vein Occlusion With Macular Edema
• Uveitic Macular Edema

Intervention

Device:
• Intravitreal injection guide (Malosa)
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
• Dual Blade Eyelid Speculum
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.

Locations

Country	Name	City	State
Philippines	Peregrine Eye and Laser Instittute	Makati City	MM

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Eye and Laser Institute

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event rate	Frequency of adverse events and serious adverse events after intravitreal injection	Immediately and up to 1 month after the intravitreal injection procedure
Secondary	Patient preference for IVI technique	Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum	Immediately post injection using single-blade speculum