NCT04455399

Time Efficiency Comparison of Two IntraVitreal Injection Techniques

Time Efficiency Comparison of Two Intravitreal Injection Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Peregrine Eye and Laser Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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
DEVICE	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.

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-01-09
• Completion: 2021-01-09
• First posted: 2020-07-02
• Last updated: 2021-04-27

Locations

1 site across 1 country: Philippines