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Clinical Trials/NCT06649604
NCT06649604Not yet recruitingNot Applicable

Alleviating Panretinal Photocoagulation Associated Ocular Pain With Vibratory Stimulation

University of Alberta1 site in 1 country50 target enrollmentStarted: October 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Pain Rating Scale

Study Overview

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.

Detailed Description

Background:

Panretinal photocoagulation (PRP) is a widely used laser treatment for proliferative diabetic retinopathy (PDR). However, the associated ocular pain can make the procedure uncomfortable, leading to increased treatment visits or missed appointments. This pain is multifactorial and can be exacerbated by factors such as anxiety and hypervigilance. Traditional pain management techniques, such as regional anesthesia, are effective but invasive and carry potential complications. Oral medications have largely proven ineffective in alleviating PRP-related pain.

The Gate-Control Theory of pain posits that non-noxious stimuli can inhibit pain signals by activating A-β fibers, effectively "closing the gate" to pain transmission through A-δ and C fibers. The most relatable example is the mother rubbing a child's knee after an impact injury in the affected region. Transcutaneous electrical nerve stimulation (TENS) which utilizes the Gate-Control Theory of pain, has been shown to reduce ocular pain during PRP. However, its use raises practical concerns, including the need to carefully adjust pulse width, intensity, and frequency for effective pain relief. Additionally, some patients may find the muscular contractions or paresthesia uncomfortable. TENS is also contraindicated in individuals who are pregnant, have epilepsy, or have pacemakers. Vibratory stimulation activates cutaneous mechanoreceptors to reduce pain during intramuscular and subcutaneous injections. This technique is safer and less invasive than TENS and is therefore an ideal candidate for evaluating its effect in pain reduction during PRP. This study has the potential for an innovative concept by utilizing a vibratory device integrated within the PRP machine headrest.

Hypothesis:

Vibratory stimulation is expected to reduce ocular pain during PRP by activating cutaneous mechanoreceptors and inhibiting pain transmission, as suggested by the Gate-Control Theory. Its non-invasive nature makes it a practical alternative to traditional pain management methods, potentially enhancing patient comfort during the procedure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

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).

Intervention: Vibration Anesthesia Device (Device)

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).

Intervention: Panretinal Photocoagulation (Procedure)

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).

Intervention: Panretinal Photocoagulation (Procedure)

Outcomes

Primary Outcomes

Pain Rating Scale

Time Frame: At time of enrolment

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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