Time Efficiency Comparison of Two IntraVitreal Injection Techniques (TIVI)

Peregrine Eye and Laser Institute

Status: Completed

Conditions: Choroidal Neovascularization; Retinal Vein Occlusion With Macular Edema; Diabetic Macular Edema; Uveitic Macular Edema; Neovascular Age-related Macular Degeneration

Treatments: Device: Intravitreal injection guide (Malosa); Device: Dual Blade Eyelid Speculum

Study type: Interventional

Funder types: Other

Identifiers

NCT04455399

20200102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intravitreal injection guide

Other group

Description:

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

Treatment:

Device: Intravitreal injection guide (Malosa)

Dual blade eyelid speculum

Other group

Description:

Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus

Treatment:

Device: Dual Blade Eyelid Speculum