Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment
NCT ID: NCT06269237
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2024-02-22
2024-07-01
Brief Summary
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Detailed Description
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MGD has been found to be associated with eyelid inflammatory disorders. Rosacea affects 5.46% of adults (range 0.09-24.1%) of whom 58% have MGD. Ocular symptoms precede cutaneous rosacea in 15 to 10% of cases, indicating the presence of subclinical variation.
Intense pulsed light (IPL) has mostly been utilized as a dermatological treatment for conditions like facial rosacea, facial erythema, acne, and seborrheic keratosis throughout the last few decades. In 2015, researchers reported the use of IPL for treating MGD to improve the signs and symptoms of DED. Two years later, the TFOS DEWS II report listed IPL as an option for treating DED. Mechanisms of IPL action include liquefication of meibum, regulate inflammation, destroy abnormal blood vessels, inhibit metalloproteinases, and photo modulation. Past studies have reported that IPL treatment modulates tear inflammatory cytokines, with improvements in tear inflammation prior to changes in dry eye signs, however, these studies have been limited by laboratory tests. It is difficult to apply in clinical practice.
Lymphotoxin-alpha (LTA) is a member of the tumor necrosis factor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein, and binds to the tumor necrosis factor receptor to play a role. LTA has been shown to be a diagnostic biomarker for dry eye in past studies. The aim of this study is to investigate the therapeutic mechanism of IPL and provide evidence for the treatment of dry eye by using a point-of-care LTA detection reagent to quantitatively compare the tear LTA levels before and after IPL treatment with traditional dry eye clinical parameters.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IPL
Participants in the group with 3 sessions of IPL, 2 weeks apart.
M22
Participants in the group with 3 sessions of IPL, 2 weeks apart. Device: Intense pulsed light IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Other Names:
• IPL
control
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart.
M22
Participants in the group with 3 sessions of IPL, 2 weeks apart. Device: Intense pulsed light IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Other Names:
• IPL
sham M22
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. Device: Intense pulsed light IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Interventions
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M22
Participants in the group with 3 sessions of IPL, 2 weeks apart. Device: Intense pulsed light IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Other Names:
• IPL
sham M22
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart. Device: Intense pulsed light IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick skin types I to IV
* capable and willing to comply with the treatment and follow-up obligations
* a determination of DED based on (a) the Ocular Surface Disease Index (OSDI) ≥13 score represents severe DED, (b) non-invasive tear film breakup time (NITBUT) of ≤5 sec, or conjunctivocorneal staining score (CS) ≥3 points according to the Japanese Dry Eye Consensus
Exclusion Criteria
* Skin defects, pigmentation, moles, scars in the treatment area, skin cancer
* Autoimmune diseases, skin allergies.
* Pregnancy or lactation
* Fitzpatrick skin type V or VI.
18 Years
90 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Guanghao Qin
Role: STUDY_CHAIR
He Eye Hospital
Central Contacts
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References
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Other Identifiers
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2023LTA
Identifier Type: -
Identifier Source: org_study_id
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