An interventional study of Intravitreal injection guide (Malosa) and Dual Blade Eyelid Speculum in Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion With Macular Edema, sponsored by Peregrine Eye and Laser Institute. Completed at 1 site in Philippines. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Peregrine Eye and Laser Institute · Not applicable, Interventional, and Treatment
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.
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.
1,473 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 200 is above the median of 51 across 984 interventional studies indexed under Macular Degeneration.
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* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Exclusion Criteria:
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
Device: Intravitreal injection guide (Malosa)
Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus
Device: Dual Blade Eyelid Speculum
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
Also known as: Malosa intravitreal injection guide
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.
Duration of intravitreal injection procedure
Duration in seconds from application to removal of single-blade or dual blade speculum
Time frame: At time of injection procedure
Adverse event rate
Frequency of adverse events and serious adverse events after intravitreal injection
Time frame: Immediately and up to 1 month after the intravitreal injection procedure
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
Time frame: Immediately post injection using single-blade speculum
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Peregrine Eye and Laser Institute