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

February 19, 2024 updated by: He Eye Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPL
Participants in the group with 3 sessions of IPL, 2 weeks apart.
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 Comparator: control
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart.
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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LTA
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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
Meibomian quality
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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
Tear Film Lipid Layer Score(TFLL)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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
Tear meniscus height (TMH)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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
Conjunctival hyperemia (RS score)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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
Ocular Surface Disease Index (OSDI)
Time Frame: Day-0 (baseline), day-21, day-42, day-63 and day-84
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Guanghao Qin, He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

June 3, 2023

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023LTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.

IPD Sharing Time Frame

The Steering Committee will write and submit the report for publication at the end of the study

IPD Sharing Access Criteria

Use in clinical studies

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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