Efficacy of Quantum Molecular Resonance in Neuropathic Corneal Pain and Corneal Nerve Regeneration

NCT07174739 | Recruiting

• 1 other identifier: 2022-2421
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate whether Quantum Molecular Resonance (QMR) treatment can effectively reduce eye pain and stimulate corneal nerve regeneration in patients with neuropathic corneal pain (NCP). Participants diagnosed with NCP will attend a total of nine study visits, consisting of one baseline assessment and eight QMR treatment sessions. At each visit, participants will undergo a series of clinical examinations to evaluate changes in the ocular surface, corneal nerves, and tear proteins, and will complete questionnaires regarding their symptoms, eye pain, and quality of life. The investigators will compare these outcomes before and after QMR treatment to determine whether QMR treatment alleviates NCP symptoms and enhances ocular surface and corneal nerve health. The investigators hypothesize that QMR treatment will provide notable pain relief, promote corneal nerve regeneration, and improve overall quality of life for NCP patients.

Conditions

Neuropathic Corneal Pain

Keywords

neuropathic corneal pain; eye pain; QMR; Quantum Molecular Resonance; Rexon-Eye

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS) to measure eye pain severity

  The VAS is used to assess patients' pain progression and to compare pain severity across different time points. The VAS will be used to measure on a scale of 0 to 10, with higher scores indicating greater pain severity. A score below 4 cm is preferred for effective chronic sensation management.

  From enrollment to the end of treatment at 8 weeks.

• Ocular Pain Assessment Survey (OPAS) questionnaire to evaluate eye pain features

  The Ocular Pain Assessment Survey (OPAS) is a 27-item questionnaire to evaluate the eye pain from 6 dimensions, including pain intensity for the last 24h, pain intensity for the last 2 weeks, non-eye pain intensity, quality of life, aggravating factors, associated factors and symptom relief. Each question was scored on a scale of 0-10, with higher score representing worse pain.

  From enrollment to the end of treatment at 8 weeks.

• Extend of corneal nerve impairment assessed by IVCM

  IVCM will be used to capture corneal nerve images before and after surgeries. The extend of corneal nerve damage will be quantified using seven nerve parameters by a specialized image analysis software (ACCMetrics software).

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (9)

• Amount of tear production measured by Schirmer's I test

  From enrollment to the end of treatment at 8 weeks.

• Corneal sensitivity measurements assessed by Cochet-Bonnet esthesiometer

  From enrollment to the end of treatment at 8 weeks.

• Level of tear film stability

  From enrollment to the end of treatment at 8 weeks.

• National Eye Institute (NEI) Score

  From enrollment to the end of treatment at 8 weeks.

• Oxford score

  From enrollment to the end of treatment at 8 weeks.

Study Arms (1)

Quantum Molecular Resonance (QMR) Treatment

EXPERIMENTAL

Participants in this arm will receive Quantum Molecular Resonance (QMR) treatment using the Rexon-Eye device for a total of eight sessions, administered once weekly, with each session lasting 30 minutes. The study consists of nine visits in total: one pre-assessment visit, followed by the eight QMR treatment sessions. The efficacy of QMR treatment will be evaluated through various aspects, including in participants' self-reported symptom relief, clinical ocular surface assessments, and IVCM evidence of corneal nerve regeneration.

Device: Quantum Molecular Resonance (QMR) Treatment

Interventions

Quantum Molecular Resonance (QMR) Treatment DEVICE

Quantum Molecular Resonance (QMR) treatment will be administered using the Rexon-Eye® device (Resono Ophthalmic, Sandrigo, Italy) according to the protocol recommended by the manufacturer. The device features a contact electrode embedded in a mask worn over the participant's closed eyes, and it delivers stimulation to the epidermis of the closed eyelids, extending up to the lid border with an intensity setting of 4-5 on a scale of 0-10. The treatment is non-invasive and painless.

Quantum Molecular Resonance (QMR) Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 21 years of age.
• Regardless of gender (Male/Female).
• Regardless of race (Chinese/Malay/Indian/Eurasian/Others).
• Diagnosed with neuropathic corneal pain based on the following criteria: presence of neuropathic ocular symptoms (burning, stinging, photophobia, pain, severe dryness), absent or minimal slit-lamp findings to explain the symptoms and corneal nerve abnormalities as detected by IVCM (decreased corneal length and density, presence of neuromas).
• Willing to receive all eye examinations in this study.

You may not qualify if:

• Pregnant women.
• Participants carrying active implantable devices (e.g., pacemakers and hearing aids).
• Oncologic patients under treatment; patient who underwent ocular surgery in the last month.
• Participants who had ocular infection within 6 months, or active ocular infection or inflammation; any concomitant ocular diseases that could potentially induce ocular pain, such as uveitis.

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, S169856, Singapore

RECRUITING

MeSH Terms

Conditions

Eye Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Central Study Contacts

Yu-Chi Liu, MD, MCI, PhD

CONTACT

65 65767287; liu.yu.chi@snec.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 16, 2025
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)