Choroidal Neovascularization, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion With Macular Edema, Uveitic Macular Edema
Conditions
Keywords
intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF
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.
Interventions
DEVICEIntravitreal 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
DEVICEDual 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.
Sponsors
Peregrine Eye and Laser Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of intravitreal injection procedure | At time of injection procedure | Duration in seconds from application to removal of single-blade or dual blade speculum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | Immediately and up to 1 month after the intravitreal injection procedure | Frequency of adverse events and serious adverse events after intravitreal injection |
| Patient preference for IVI technique | Immediately post injection using single-blade speculum | Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum |
Countries
Philippines
Outcome results
None listed