The effect of intense pulsed light combined with topical 0.05% cyclosporin an eyedrops in the treatment of Sjögren’s syndrome related dry eye

ABSTRACT

Objectives

This study aimed to assess the effectiveness and safety of intense pulsed light (IPL) therapy plus topical 0.05% cyclosporine A (CsA) eye drops to treat Sjögren’s Syndrome-related dry eyes (SS-DE).

Research design and methods

In this prospective, randomized trial included, 60 individuals with SS-DE symptoms were randomized to receive topical eye drops containing either 0.1% sodium hyaluronate (Group S) or 0.05% CsA (Group C) plus IPL therapy. Before the first treatment (baseline), and at 12, 16, and 20 weeks after treatment commencement, we assessed the best corrected visual acuity (BCVA), the Ocular Surface Disease Index (OSDI) score, the Schirmer I test (SIT), noninvasive tear breakup time (NBUT), corneal fluorescein staining (CFS), meibomian gland (MG) dropout, lid margin abnormality, MG expressibility, and meibum quality.

Results

Both groups showed significant improvements in the OSDI, NBUT, CFS, MG expressibility, and meibum quality (all p < 0.05). Group C showed a greater increase in OSDI, NBUT, MG expressibility, and meibum quality (all p < 0.05). Moreover, SIT and lid margin abnormalities significantly improved in Group C (both p < 0.05), but not in Group S.

Conclusion

Treatment with 0.05% CsA eyedrops plus IPL therapy could significantly reduce the issues and physical discomfort of patients with SS-DE.

Clinical Trial

Registered on 20 July 2021, with the registration number ChiCTR2100049059.

KEYWORDS:

• Sjögren’s syndrome
• dry eye
• intense pulsed light
• cyclosporine A
• anti-inflammatory

Article highlights

• The symptoms and signs of SS-DE are extremely significant, and managing it can be challenging.

• For patients with SS-DE, we provide a novel combination therapy that is both effective and safe.

• The OSDI, NITBUT, CFS, MG expressibility, and meibum quality significantly improved in the IPL combined CsA eyedrops group as well as the IPL combined sodium hyaluronate eyedrops group.

• The IPL combined CsA eyedrops group demonstrated a significantly higher increase in meibum quality, MG expressibility, NITBUT, and OSDI.

• SIT and lid margin abnormalities significantly improve in the IPL coupled CsA eyedrops group, while they did not in the control group.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

This study was approved by the Ethics Committee of The Second Affiliated Hospital of Zhejiang University School of Medicine (Approval No. 2021–0653). The study was conducted in compliance with the Declaration of Helsinki for research involving human subjects.

Author contributions

Conceptualization, X Jin; Data curation, Y Huo, Y Mou, Formal analysis, X Huang; Funding acquisition, Y Huo; Investigation: Y Huo, L Lin; Methodology: S Yang; Project administration, X Jin; Software, Y Zhu; Supervision, X Jin; Writing-original draft, Y Huo, Z Qin; Writing review & editing, Y Huo, X Jin.

Data sharing statement

Individual deidentified participant data (including data dictionaries) will be shared. All the individual participant data collected during the trial, after de-identification, Study Protocol, Statistical Study Protocol, Statistical Analysis Plan, Analytic Code, and Study Protocol will be available beginning 6 months and ending 1 year following article publication to anyone who wishes to access the data to achieve aims in the approved proposal. Proposals should be directed to [email protected]. Data requestors will need to sign a data access agreement.

Additional information

Funding

The paper was funded by Zhejiang Provincial Natural Science Foundation Key Program of China [Z24H120002], Health Commission of Zhejiang Province [2022KY168].