The aim of the current study is to investigate changes of tear cytokines levels as well as the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients with meibomian gland dysfunction-Associated demodicosis. The effect of OPT IPL will be examined in a study designed as a randomised controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of OPT IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the OPT IPL pulses will be disabled. For each subject, the duration of the study will be 2 months , as explained in the detailed description.
All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with Optimal pulsed technology intense pulsed light (OPT IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the OPT IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the OPT IPL administration will be sham. A single follow-up will occur at 2 months after the baseline (or 2 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms. For each subject, the duration of the study will be 2 months: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 8 weeks after baseline). Statistically significant differences between the two arms will support the study hypothesis that IPL treatment is potentially reduce demodex counts and decrease levels of cytokines , and relief to both signs and symptoms of dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Sham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side.
The First affiliated hospital of harbin medical university
Harbin, Heilongjiang, China
change of baseline demodex counts
Six lashes with cylindrical dandruff (CD) were epilated from each eye (3 in upper eyelid and 3 in lower eyelid) under slit lamp and mounted on glass slides and were examined under optical microscopy to confirm the presence of D folliculorum. Demodex counts greater than or equal to 1 were Demodex-positive.
Time frame: 2 months
change of baseline tear cytokines levels
Change of IL-1α, IL-1β, IL-6, IL-7, IL-12p40, IL-13, IL-17A, IL-8, MMP-3, MMP-9 in the study eye, from baseline to follow-up, in both eyes
Time frame: 2 months
Change from baseline of Ocular Surface Disease Index score
The ocular surface disease index score was assessed as a subjective parameter to evaluate the ocular symptoms of dry eye on a score of zero to 100, and subject with a score of greater than 12 was considered abnormal.
Time frame: 2 months
change from baseline of schirmer I test
Schirmer I test (without anesthesia) was used to assess tear production by inserting in each eye a sterile dry strip (Jingming, Tianjin, China) into the lateral canthus of the lower eyelid away from the cornea over 5 minutes. The length of the strip that was wetted by absorbed tears was then measured in millimeter to evaluate tear secretion function. Values of less than 7.0 mm are considered a diagnosis of aqueous tear deficiency.
Time frame: 2 months
change from baseline of the Lid margin abnormalities score
The slit-lamp biomicroscopy was used to score the lid margin abnormalities: the following four parameters were scored as 0 (absent) or 1 (present) of lid margin abnormalities: lid margin irregularity, plugging of the meibomian orifices, lid margin vascular engorgement, and anterior or posterior replacement of mucocutaneous junction. The sum was recorded as 0-4.
Time frame: 2 months
change from baseline of meibum grade score
Meibum grade was assessed in each of eight glands of the central third of the lower lid on a scale of zero to three for each gland: zero (clear), one (cloudy), two (cloudy with debris, granular) and three (thick, like toothpaste). Total score range, 0 to 24
Time frame: 2 months
change from baseline of corneal fluorescein staining score
The corneal fluorescein staining score was assessed by instilling fluorescein into the lower conjunctival sac with a fluorescein strip (Jingming, Tianjin, China) moistened with preservative-free saline solution. The grading system recommended by NEI divides the cornea into 5 zones (central, superior, temporal, nasal and inferior). For each zone, the corneal fluorescein staining score was graded on a scale from 0 to 3. Therefore, the maximum score was 15
Time frame: 2 months
change of baseline of lashes in vivo confocal microscopy laser
In vivo confocal microscopy laser (IVCM, HRTII Cornea Module; Heidelberg Engineering GmbH, Dossenheim, Germany) was used to examine almost 10-20 eyelashes in both eyes. Demodex folliculorum identified in the infundibulum of the eyelashes and the space adjacent to the eyelash shafts as hypo-reflective elongated bodies with a hyperreflective head. Demodex counts greater than or equal to 1were considered positive.
Time frame: 2 months
change from baseline of fluorescein tear break up time
The fluorescein tear beak up time was evaluated immediately after the assessment of staining. The patient was required to blink several times to ensure adequate coating of the dye on the cornea. Using a cobalt blue filter and slit-lamp biomicroscopy, the interval between the last complete blink and appearance of the first dry spot in the stained tear film was recorded as the fluorescein tear beak up time. The test was repeated 3 times and the average fluorescein tear beak up time was calculated in second. Values of less than 10 seconds are considered abnormal.
Time frame: 2 months
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