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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal injection guide | Other | 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 |
|
| Dual blade eyelid speculum | Other | Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection guide (Malosa) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of intravitreal injection procedure | Duration in seconds from application to removal of single-blade or dual blade speculum | At time of injection procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Frequency of adverse events and serious adverse events after intravitreal injection | Immediately and up to 1 month after the intravitreal injection procedure |
| Patient preference for IVI technique |
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Inclusion Criteria:
* Eyes of adult patients requiring intravitreally injected medications for non-infectious indications
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harvey S Uy, MD | Peregrine Eye and Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peregrine Eye and Laser Instittute | Makati City | MM | 1209 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34135566 | Derived | 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. |
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Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
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|
| Dual Blade Eyelid Speculum | Device | 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. |
|
Patient survey as to which technique is more comfortable and preferred among patients with prior injection experience using the dual blade speculum
| Immediately post injection using single-blade speculum |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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