Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye
NCT Number: NCT06576245
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye
Interventions: DEVICE: Quantum Molecular Resonance (QMR) Therapy|DEVICE: Intense Pulsed Light (IPL) Therapy|DRUG: Tear Substitute Treatment (Supportive Therapy)
Sponsor: University of Seville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-02-28
Locations: Tedesco Eye Center, Girifalco, Catanzaro, 88024, Italy

Summary:
This study examines the effectiveness of combining Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) treatments for Mixed Dry Eye, a condition where both tear production and tear quality are compromised. Twenty-five patients received both treatments over a period of six weeks, and their symptoms and tear quality were monitored for three months.

Primary Outcome Measures: Improvement in Ocular Surface Disease Index (OSDI) Score, The Ocular Surface Disease Index (OSDI) is a patient-reported questionnaire used to assess the severity of dry eye symptoms. It includes 12 items, with scores ranging from 0 (no symptoms) to 100 (severe symptoms). The change in OSDI score from baseline to 1 month and 3 months after treatment will be measured. A significant reduction in OSDI score indicates an improvement in dry eye symptoms., Baseline, 1 month, 3 months
Secondary Outcome Measures: Change in Lipid Layer Thickness (LLT), Lipid Layer Thickness (LLT) of the tear film will be measured using the Lipiview II ocular surface interferometer. The LLT is expressed in nanometers (nm) and reflects the thickness of the lipid layer in the tear film. The change in LLT from baseline to 1 month and 3 months after treatment will be assessed to determine the effectiveness of the combination therapy in improving tear film stability., Baseline, 1 month, 3 months|Change in Non-Invasive Tear Film Break-Up Time (NIBUT), Non-Invasive Tear Film Break-Up Time (NIBUT) will be measured using the Keratograph 5M. NIBUT is the time taken for the tear film to break up after a blink, without the use of dyes or invasive techniques. It will be recorded in seconds. An increase in NIBUT indicates improved tear film stability. The change in NIBUT will be evaluated from baseline to 1 month and 3 months after treatment., Baseline, 1 month, 3 months|Change in Schirmer I Test (ST) Score, The Schirmer I Test (ST) measures tear production. A strip of filter paper is placed under the lower eyelid, and the length of the wet portion of the strip is measured in millimeters after 5 minutes. The test is performed without anesthesia. The change in ST score from baseline to 1 month and 3 months after treatment will be used to assess improvements in tear production., Baseline, 1 month, 3 months
Other Outcome Measures: Correlation Between Clinical Endpoints and Symptom Improvement, This exploratory outcome measure will analyze the correlation between clinical endpoints (such as NIBUT, LLT, and ST) and the improvement in OSDI scores. The goal is to determine which clinical measures most strongly predict symptom improvement., 3 months