Time Efficiency Comparison of Two IntraVitreal Injection Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Time Efficiency Comparison of Two Intravitreal Injection Techniques

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

Intervention / Treatment
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* Device: Intravitreal injection guide (Malosa)
* Device: Dual Blade Eyelid Speculum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intravitreal injection guide<br>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)<br>* 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<br>* Other names: Malosa intravitreal injection guide;|
| Other: Dual blade eyelid speculum<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravitreal injection, intravitreal injecton guide, macular edema, time efficiency, anti-VEGF