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

NCT06269237 | Unknown DMC

• 1 other identifier: 2023LTA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye

Keywords

dry eye; intense pulsed light; Lymphotoxin alpha

Outcome Measures

Primary Outcomes (2)

• 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 (LTα3) 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

• 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 Outcomes (6)

• Fluorescein and lissamine conjunctival and cornea staining (CFS)

  Day-0 (baseline), day-21, day-42, day-63 and day-84

• Meibomian quality

  Day-0 (baseline), day-21, day-42, day-63 and day-84

• Tear Film Lipid Layer Score(TFLL)

  Day-0 (baseline), day-21, day-42, day-63 and day-84

• Tear meniscus height (TMH)

  Day-0 (baseline), day-21, day-42, day-63 and day-84

• Conjunctival hyperemia (RS score)

  Day-0 (baseline), day-21, day-42, day-63 and day-84

Study Arms (2)

IPL

EXPERIMENTAL

Participants in the group with 3 sessions of IPL, 2 weeks apart.

Device: M22

control

SHAM COMPARATOR

Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart.

Device: M22; Device: sham M22

Interventions

M22 DEVICE

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

IPL; control

sham M22 DEVICE

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.

control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• He Eye Hospital: lead

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MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Guanghao Qin

  He Eye Hospital

  STUDY CHAIR

Central Study Contacts

Guanghao Qin

CONTACT

+8618842664420; qinguanghao@hsyk.com.cn

Chen Jiayan

CONTACT

+8618304019060; chenjiayan@hsyk.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: February 21, 2024
• Study Start: February 22, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The Steering Committee will write and submit the report for publication at the end of the study
• Access Criteria: Use in clinical studies