About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Quantum Molecular Resonance (QMR) Treatment
DeviceQuantum 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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).
Secondary outcomes
Amount of tear production measured by Schirmer's I test
Schirmer's I test is a diagnostic method used to measure tear production by placing a standard 5 mm wide Test Strips inside the lower lid margin and assessing the amount of tear absorbed over 5 minutes.
Corneal sensitivity measurements assessed by Cochet-Bonnet esthesiometer
Corneal sensitivity measurements assess the responsiveness of the cornea to external stimuli using a contact Cochet-Bonnet esthesiometer, which employs a retractable nylon filament marked from 0 to 6 cm. The filament is progressively shortened in 0.5 cm increments until the participant perceives the stimulus. The maximum filament length that successfully triggers a response is recorded in centimeters as a measure of corneal sensitivity.
Level of tear film stability
Tear Break-up time (TBUT) will be measured by determining the time interval between a complete blink and the first appearance of a dry spot on the corneal surface, indicating tear film stability.
National Eye Institute (NEI) Score
The cornea will be divided into five regions, each scored ranging from 0 (no fluorescein staining) to 3 (severe fluorescein staining) according to the grading scheme. The total NEI score will range from 0 to 15.
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