Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment

Dry Eye Clinical Trial

Official title:

Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269237
• Other study ID #: 2023LTA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: He Eye Hospital
• Contact: Guanghao Qin
• Phone: +8618842664420
• Email: qinguanghao[@]hsyk.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment.

Description:

Dry eye is multifactorial, mainly manifested as eye pain, visual impairment (blurred and blurry vision), tear film instability, and tear film hypertonicity, which can cause ocular surface damage. Some possible causes of DED include aging, menopause, Meibomian gland dysfunction (Meibomian gland dysfunction; MGD), Sjogren's syndrome, conjunctival fibrotic disease, refractive surgery, and systemic or topical drugs. Insufficient tear secretion or excessive tear evaporation has been demonstrated to cause precorneal tear concentration or hypertonicity, which disrupts tear film homeostasis. Tear film hypertonicity can cause cell morphological changes, inflammatory cascades, cell death, tear film instability, and further lead to tear hypertonicity. Mgd-induced Evaporative dry eye; EDE) is the most common form of dry eye]. Anti-inflammatory drugs, antibiotics, hot compress, eyelid cleaning and meibomian gland expression are the treatment standards for MGD. However, its long-term efficacy is not satisfactory due to poor patient compliance.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age = 18 years

• 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:

• Existing ocular trauma, infectious diseases, recent surgical history

• Skin defects, pigmentation, moles, scars in the treatment area, skin cancer

• Autoimmune diseases, skin allergies.

• Pregnancy or lactation

• Fitzpatrick skin type V or VI.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LTA	Lymphotoxin-alpha (LTA) is a member of the tumor necrosisfactor (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 (LTa3) as a soluble protein [23], and binds to the tumor necrosis factor receptor to play a role. LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.	Day-0 (baseline), day-21, day-42, day-63 and day-84
Primary	Non-invasive tear break-up time (NITBUT)	Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer.; Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Fluorescein and lissamine conjunctival and cornea staining (CFS)	Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface. Higher scores means worse.	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Meibomian quality	Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum)	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Tear Film Lipid Layer Score(TFLL)	Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed.	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Tear meniscus height (TMH)	TMH using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded.	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Conjunctival hyperemia (RS score)	Conjunctival hyperemia (RS score) will be assessed by Keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 (normal) to 4.0 (severe).	Day-0 (baseline), day-21, day-42, day-63 and day-84
Secondary	Ocular Surface Disease Index (OSDI)	The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome	Day-0 (baseline), day-21, day-42, day-63 and day-84