Clinical Study Evaluating Nordlys™ System with Selective Waveband Technology (SWT)® Intense Pulsed Light (IPL) Applicators for Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD).
Subjects will be randomized 1:1 to an experimental study group and a sham comparator (control) group. Subjects in the experimental group will receive four (4) IPL treatments and meibomian gland expression (MGX) at 2-week intervals. IPL pulses will be administered on the skin of the malar region and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Subjects in the control group will receive the same treatment (IPL followed by MGX), except that the IPL administration will be performed with the device off (sham treatment). Follow-up visits will occur at 1 month and 3 months after the final treatment session. At the follow-up, the changes in the outcome measures will be evaluated and compared between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators
Meibomian glands are squeezed (by applying force on the inner and outer surfaces of the eyelid with a specially designed forceps, Q-tips, or fingers) in order to unclog obstructed glands and evacuate their content (the meibum), which in MGD is often viscous and thus causing obstruction
Sham treatment with Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators device turned off
Center for Excellence in Eye Care
Miami, Florida, United States
Candela Institute of Excellence
Marlborough, Massachusetts, United States
Av. Del Libertador 662, Piso 17, Dept. 42
Buenos Aires, Argentina
Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up
The difference in the change of TBUT from Baseline to Follow-Up, between eyes in the study group and eyes in the control group. TBUT is measured in seconds. Improvement is defined as a positive change of TBUT from Baseline to Follow Up. Measurement of TBUT will be implemented using fluorescein ophthalmic strips. Three successive readings will be taken and averaged to a single value.
Time frame: Baseline, 4-Week Follow Up (Week 10)
Difference in change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up.
The difference in the change of OSDI from baseline to FU, between subjects in the study group and subjects in the control group. The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye. The improvement of OSDI is defined as a negative change of OSDI from BL to FU.
Time frame: Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18
The difference in change of self-assessed symptoms of eye dryness via Eye Dryness Score (EDS) via visual analog scale (VAS), from baseline to follow-up
A qualitative test to visualize the production of sweat to the affected body area and assist in determining the area requiring treatment. Values will be collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. The improvement of EDS is defined as a negative change of EDS from baseline to follow-up.
Time frame: Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.