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Reducing Pain From Retinal Laser With Vibrational Stimulation

NCT06649604 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Vibration Anesthesia Device works to reduce pain during retinal laser for diabetic retinopathy. The main question it aims to answer is:

Does the Vibration Anesthesia Device reduces the pain felt by patients during the laser treatment? Researchers will compare the standard method (no vibration device) to the standard method with the Vibration Anesthesia Device to see if the device works to reduce discomfort during treatment.

Eligible participants will have both eyes treated as required, one eye with the device and the other one without. Both the side that will be treated with the device in place and the first side to be treated will be decided by random sequence.

Conditions

  • Pain, Perioperative

Interventions

DEVICE

Vibration Anesthesia Device

The intervention arm of this study is distinguished by way of the use of the Vibration Anesthesia Device

PROCEDURE

Panretinal Photocoagulation

Laser treatment for diabetic retinopathy done in a standard fashion

Sponsors & Collaborators

  • Alberta Retina Consultant

    collaborator UNKNOWN

  • University of Alberta

    lead OTHER

Principal Investigators

  • Matthew Tennant, MD, FRCSC · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2027-04-01
Completion
2027-05-01
FDA Device
Yes

Countries

  • Canada

Study Locations

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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 NCT06649604 on ClinicalTrials.gov