Reducing Pain From Retinal Laser With Vibrational Stimulation

NCT06649604 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00144813
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vibration Anesthesia Device; Perioperative Pain Alleviation; Panretinal Photocoagulation; Diabetic retinopathy treatment

Outcome Measures

Primary Outcomes (1)

• Pain Rating Scale

  Patient are enrolled on the same day as the study treatment. Patients will rate their pain sensation. They will have their first eye (left or right and with or without the Anesthesia Vibration Device based on randomization) treated, then they will assess their pain sensation. After this assessment, during the same session, their second eye will be treated and they will be asked to complete the same assessment for this second eye. The provided form to assess this outcome is a numeric scale from 0 (no pain) to 10 (worst possible pain) using the Wong-Baker Faces scale.

  At time of enrolment

Study Arms (2)

PRP with the Vibration Anesthesia Device

EXPERIMENTAL

Laser for PRP treatment as usual, but with the addition of the Vibration Device in one of the two eyes of a patient (The other eye receiving the same laser treatment without the device).

Device: Vibration Anesthesia Device; Procedure: Panretinal Photocoagulation

PRP without the Vibration Anesthesia Device

ACTIVE COMPARATOR

Laser for PRP treatment as usual in one of the two eyes of a patient (other eye receiving the same treatment, but with the Vibration Device).

Procedure: Panretinal Photocoagulation

Interventions

Vibration Anesthesia Device DEVICE

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

PRP with the Vibration Anesthesia Device

Panretinal Photocoagulation PROCEDURE

Laser treatment for diabetic retinopathy done in a standard fashion

PRP with the Vibration Anesthesia Device; PRP without the Vibration Anesthesia Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naïve patients
• Bilateral PRP for proliferative diabetic retinopathy required
• \>500 applications to each eye
• \< 51 applications difference between each eye, in the superior or inferior hemisphere.

You may not qualify if:

• Poor pupil dilation \< 5mm
• Media opacity preventing laser

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Retina Consultant: collaborator

Study Sites (1)

Alberta Retina Consultant

Edmonton, Alberta, T5H 0X5, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Tennant, MD, FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu Carrière, MD, FRCSC

CONTACT

(780) 448-1801; mcarrie2@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the collaborator who will analyse the data will be masked, due to the manifest presence or absence of the vibratory device for both the clinician and the patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patient are their own control, using laser in both eyes, but only one using the Vibration Anesthesia Device.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 21, 2024
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)