Research AppraisalRandomised Controlled Trial

Safety and efficacy of Vectored thermal pulsation, Intense pulsed light, and Eyelid Warm compress therapies (VIEW) for meibomian gland dysfunction: Study design and baseline characteristics of a randomized controlled trial

PloS oneHu, Zhichao, Wong, Hanson Yiu Man, Chan, Emily Hoi Ying et al.DOI

Clinical Snapshot

65CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — Population360 symptomatic adults with mild to moderate meibomian gland dysfunction (MGD), mean age 54.4 ± 14.7 years
I — InterventionVectored thermal pulsation (VTP) single session, or Intense pulsed light plus meibomian gland expression (IPL + MGX) four sessions over 3 months
C — ComparatorEyelid warm compress (EW) twice daily for 15 months
O — OutcomesPrimary: Tear film break-up time (TFBUT) at 6 and 15 months. Secondary: Safety, therapeutic efficacy, longevity, and compliance measures

Bottom Line

This well-designed RCT protocol represents the first head-to-head comparison of three physical MGD treatments. The study addresses an important clinical question as MGD affects millions globally and current treatment evidence is limited to individual intervention studies. While the inability to blind participants to physical treatments introduces performance bias, assessor masking and standardized co-interventions strengthen the design. The 16-month follow-up will provide valuable data on treatment durability. However, the unequal treatment intensity (single VTP session vs. four IPL sessions vs. daily warm compresses) may complicate interpretation. Australian clinicians should await the results to inform evidence-based MGD management, particularly regarding cost-effectiveness of device-based treatments versus conservative management. The study's comprehensive outcome assessment including patient-reported measures will provide clinically relevant data for shared decision-making with MGD patients.

Evidence: Moderate

Key Findings

  • P Value: Not reported - protocol paper

  • Effect Size: Not reported - protocol paper

  • Primary Outcome: Tear film break-up time (TFBUT) at 6 and 15 months

  • Nnt Or Sensitivity: Not reported - protocol paper

  • Confidence Interval: Not reported - protocol paper

Clinical Application

VTP and IPL+MGX require specialized equipment and training; warm compresses are readily accessible but require patient compliance IPL and thermal pulsation devices available in Australia but not PBS-subsidized. Warm compresses cost-effective. Results may inform TGA device approvals and RANZCO treatment guidelines Adults with symptomatic mild to moderate MGD, particularly those considering physical treatment options beyond artificial tears

Abstract

BACKGROUND: Meibomian gland dysfunction (MGD) is one of the most prevalent chronic eye diseases, characterized by meibomian gland obstruction and abnormal meibum secretion both in quantity and quality. OBJECTIVE: To assess the efficacy and safety of vectored thermal pulsation (VTP), intense pulsed light plus meibomian gland expression (IPL + MGX), and eyelid warm compress (EW). METHODS: This is a 3-arm, assessor-masked, randomized controlled trial. 360 symptomatic mild to moderate MGD subjects would be recruited and randomized into 3 intervention groups. Subjects from Group-A, Group-B, and Group-C would be treated with one-session VTP (at baseline), four-session IPL + MGX (at baseline, month-1, month-2, and month-3 visits), and twice-daily EW for 15 months, respectively. All subjects would be prescribed topical artificial tears (Hypromellose, 0.3% w/v) to be used as frequently as needed from wash-out (1 month before baseline) to endpoint (month-15 visit). Subjects would be assessed 9 times throughout a total of 16-month study period. Five self-administered questionnaires would be collected each time in random order. Masked observers would conduct examinations using slit-lamp biomicroscopy, LipiView® II, and Keratograph 5M machines. The eye with worse MGD would be selected and analyzed as the study eye. Tear film break-up time (TFBUT) at month-6 and month-15 visits are the primary outcomes. RESULTS: 374 subjects were enrolled and randomized into three groups, and 372 subjects (aged 54.4 ± 14.7 years) were finally analyzed. The mean of TFBUT time at baseline was 3.1 ± 1.7 seconds. CONCLUSION: This is the first head-to-head comparison of three physical treatments for mild to moderate MGD on their therapeutic efficacy, safety, longevity and compliance in a randomized controlled trial setting.

References

  1. 1.Hu, Z., Wong, H. Y. M., Chan, E. H. Y., Choy, E. K. H., Ng, A. C. F., Liao, X., Aljufairi, F. M. A. A., Uy Sebastian, J., Lai, K. K. H., Poon, C. Y. S., Chen, W., Chow, V. W. S., Tham, C. C. Y., Pang, C. P., & Chong, K. K. L. (2026). Safety and efficacy of Vectored thermal pulsation, Intense pulsed light, and Eyelid Warm compress therapies (VIEW) for meibomian gland dysfunction: Study design and baseline characteristics of a randomized controlled trial. *PLoS One*. https://doi.org/10.1016/j.pdpdt.2025.104630
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