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Time Efficiency Comparison of Two IntraVitreal Injection Techniques

NCT04455399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

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

Interventions

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

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.

Sponsors & Collaborators

  • Peregrine Eye and Laser Institute

    lead OTHER

Principal Investigators

  • Harvey S Uy, MD · Peregrine Eye and Laser Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-01-09
Completion
2021-01-09

Countries

  • Philippines

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455399 on ClinicalTrials.gov