Clinical trial NCT04455399: Time Efficiency Comparison of Two IntraVitreal Injection Techniques
Official title: Time Efficiency Comparison of Two Intravitreal Injection Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion With Macular Edema
Uveitic Macular Edema
Choroidal Neovascularization
Keywords: intravitreal injection
intravitreal injecton guide
macular edema
time efficiency
anti-VEGF
Lead sponsor: Peregrine Eye and Laser Institute
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of intravitreal injection procedure
timeFrame: At time of injection procedure
Secondary outcomes:
measure: Adverse event rate
timeFrame: Immediately and up to 1 month after the intravitreal injection procedure
measure: Patient preference for IVI technique
timeFrame: Immediately post injection using single-blade speculum
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Peregrine Eye and Laser Instittute
state: MM
Study officials:
affiliation: Peregrine Eye and Laser Institute
name: Harvey S Uy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.