Time Efficiency Comparison of Two IntraVitreal Injection Techniques (TIVI)

Time Efficiency Comparison of Two Intravitreal Injection Techniques

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Choroidal Neovascularization; Neovascular Age-related Macular Degeneration; Uveitic Macular Edema; Retinal Vein Occlusion With Macular Edema
• Intervention / Treatment: Device: Intravitreal injection guide (Malosa); Device: Dual Blade Eyelid Speculum

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • MM
    • Makati City, MM, Philippines, 1209
      • Peregrine Eye and Laser Instittute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peregrine Eye and Laser Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): January 9, 2021
• Study Completion (Actual): January 9, 2021

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 25, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: macular edema; intravitreal injection; anti-VEGF; intravitreal injecton guide; time efficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Uveal Diseases; Venous Thrombosis; Thrombosis; Choroid Diseases; Metaplasia; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Choroidal Neovascularization; Neovascularization, Pathologic; Edema
• Other Study ID Numbers: 20200102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No