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OpenTrials
Completed

NCT Number: NCT04455399

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Choroid Diseases Choroidal Neovascularization Diabetic Macular Edema Eye Diseases Macular Degeneration Macular Edema Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion With Macular Edema Uveal Diseases Uveitic Macular Edema

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peregrine Eye and Laser Instittute

Makati City, MM, 1209, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Malosa intravitreal injection guide

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.

Primary outcomes

  1. Duration of intravitreal injection procedure

    Time frame: At time of injection procedure

    Duration in seconds from application to removal of single-blade or dual blade speculum

Secondary outcomes

  1. Adverse event rate

    Time frame: Immediately and up to 1 month after the intravitreal injection procedure

    Frequency of adverse events and serious adverse events after intravitreal injection

  2. Patient preference for IVI technique

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peregrine Eye and Laser Institute

Other

Registry information

Acronym: TIVI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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