TIVI: Time Efficiency Comparison of Two IntraVitreal Injection Techniques

Sponsor

Peregrine Eye and Laser Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04455399

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

99.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion With Macular Edema Uveitic Macular Edema Choroidal Neovascularization	Device: Intravitreal injection guide (Malosa) Device: Dual Blade Eyelid Speculum	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)Intravitreal Injection Guide (Malosa, Beaver Visitec International, Waltham, MA)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Time Efficiency Comparison of Two Intravitreal Injection Techniques

Actual Study Start Date :

Nov 9, 2020

Actual Primary Completion Date :

Jan 9, 2021

Actual Study Completion Date :

Jan 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Intravitreal injection guide 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) 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 Other Names: Malosa intravitreal injection guide
Other: Dual blade eyelid speculum 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 conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.

Arm

Intervention/Treatment

Other: Intravitreal injection guide

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)

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

Other Names:

Malosa intravitreal injection guide

Other: Dual blade eyelid speculum

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 conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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