Randomized Controlled Trial

. 2021 Nov 17;11(1):22386.

doi: 10.1038/s41598-021-01899-8.

TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial

Jonatan Olafsson^{1

2}, Xiaoran Lai³, Erlend Christoffer Sommer Landsend⁴, Snorri Olafsson^{5

6}, Eric Parissi⁷, Øygunn A Utheim^{8

9

10}, Sten Raeder^{8

10}, Reza A Badian^{9

10

11}, Neil Lagali^{12

13}, Darlene A Dartt¹⁴, Tor P Utheim^{9

10

4

11

13

15}

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway. jonatanolaf@gmail.com.
² Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway. jonatanolaf@gmail.com.
³ Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Blindern, P.O. Box 1122, 0317, Oslo, Norway.
⁴ Department of Ophthalmology, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
⁵ Department of Gastroenterology, Innlandet Hospital Trust, Kyrre Grepps gate 11, 2816, Gjøvik, Norway.
⁶ Loma Linda University Medical Center, 11234 Anderson St., Loma Linda, CA, 92354, USA.
⁷ Lavista Optometry, Dampsagveien 4, 2000, Lillestrom, Norway.
⁸ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway.
⁹ Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
¹⁰ The Norwegian Dry Eye Clinic, Ole Vigs gate 32E, 0366, Oslo, Norway.
¹¹ Department of Optometry, Radiography and Lighting, National Centre for Optics, Vision and Eye Care, Faculty of Health and Social Sciences, University of Southeast Norway, P.O. Box 235, 3603, Kongsberg, Norway.
¹² Division of Ophthalmology, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.
¹³ Department of Ophthalmology, Sørlandet Hospital Arendal, Sykehusveien 1, 4838, Arendal, Norway.
¹⁴ Department of Ophthalmology, Schepens Eye Research Institute/Massachusetts Eye and Ear, Harvard Medical School, 20 Staniford St., Boston, MA, 02114, USA.
¹⁵ Department of Ophthalmology, Stavanger University Hospital, P.O. Box 8100, 4068, Stavanger, Norway.

PMID: 34789807
PMCID: PMC8599702
DOI: 10.1038/s41598-021-01899-8

Randomized Controlled Trial

TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial

Jonatan Olafsson et al. Sci Rep. 2021.

. 2021 Nov 17;11(1):22386.

doi: 10.1038/s41598-021-01899-8.

Authors

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway. jonatanolaf@gmail.com.
² Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway. jonatanolaf@gmail.com.
³ Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Blindern, P.O. Box 1122, 0317, Oslo, Norway.
⁴ Department of Ophthalmology, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
⁵ Department of Gastroenterology, Innlandet Hospital Trust, Kyrre Grepps gate 11, 2816, Gjøvik, Norway.
⁶ Loma Linda University Medical Center, 11234 Anderson St., Loma Linda, CA, 92354, USA.
⁷ Lavista Optometry, Dampsagveien 4, 2000, Lillestrom, Norway.
⁸ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372, Oslo, Norway.
⁹ Department of Medical Biochemistry, Oslo University Hospital, Nydalen, P.O. Box 4950, 0424, Oslo, Norway.
¹⁰ The Norwegian Dry Eye Clinic, Ole Vigs gate 32E, 0366, Oslo, Norway.
¹¹ Department of Optometry, Radiography and Lighting, National Centre for Optics, Vision and Eye Care, Faculty of Health and Social Sciences, University of Southeast Norway, P.O. Box 235, 3603, Kongsberg, Norway.
¹² Division of Ophthalmology, Department of Biomedical and Clinical Sciences, Linköping University, 581 83, Linköping, Sweden.
¹³ Department of Ophthalmology, Sørlandet Hospital Arendal, Sykehusveien 1, 4838, Arendal, Norway.
¹⁴ Department of Ophthalmology, Schepens Eye Research Institute/Massachusetts Eye and Ear, Harvard Medical School, 20 Staniford St., Boston, MA, 02114, USA.
¹⁵ Department of Ophthalmology, Stavanger University Hospital, P.O. Box 8100, 4068, Stavanger, Norway.

PMID: 34789807
PMCID: PMC8599702
DOI: 10.1038/s41598-021-01899-8

Abstract

Meibomian gland dysfunction (MGD) is the most common cause of dry eye disease (DED). In this study, we aimed to compare the effects of eyelid warming treatment using either TheraPearl Eye Mask (Bausch & Lomb Inc., New York, USA) or Blephasteam (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) in a Norwegian population with mild to moderate MGD-related DED. An open label, randomized comparative trial with seventy patients (49 females, 21 males; mean age 53.6 years). Patients were randomly assigned to treatment with Blephasteam (n = 37) or TheraPearl (n = 33). All received a hyaluronic acid based artificial tear substitute (Hylo-Comod, Ursapharm, Saarbrücken, Germany). Patients were examined at baseline, and at three and six months initiation of treatment. Treatment efficacy was primarily evaluated by fluorescein breakup time (FBUT) and Ocular Surface Disease Index (OSDI) scores. Other outcome measures included ocular surface staining (OSS), Schirmer's test, and meibomian quality and expressibility. Baseline parameter values did not differ between the groups. After six months of treatment, Blephasteam improved FBUT by 3.9 s (p < 0.01) and OSDI by 13.7 (p < 0.01), TheraPearl improved FBUT by 2.6 s (p < 0.01) and OSDI by 12.6 (p < 0.01). No difference between treatments was detected at 6 months (p = 0.11 for FBUT and p = 0.71 for OSDI), nor were there differences in the other tested parameters between the treatment groups. Blephasteam and TheraPearl are equally effective in treating mild to moderate MGD in a Norwegian population after 6-months of treatment.Clinicaltrials.gov ID: NCT03318874; Protocol ID: 2014/1983; First registration: 24/10/2017.

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Conflict of interest statement

Snorri Olafsson is on the speaker bureau for Takeda Pharmaceuticals. Tor Paaske Utheim is co-founder and co-owner of The Norwegian dry eye clinic, which delivers talks for and/or receives financial support from the following: ABIGO, Alcon, Allergan, AMWO, Bausch&Lomb, European school for advanced studies in ophthalmology, InnZ Medical, Medilens Nordic, Medistim, Novartis, Santen, Specsavers, Shire and Thea Laboratoires. He has served on the global scientific advisory board for Novartis and Alcon as well as the European advisory board for Shire. Utheim is the Norwegian Global Ambassador for Tear Film and Ocular Surface Society (TFOS) and a board member of the International Ocular Surface Society. Sten Raeder has financial disclosers for Abigo, Alcon, AMWO, Bausch & Lomb, Medilens, Medistim, Novartis, Santen, Théa. In addition, he has co-founded the Norwegian Dry Eye Clinic. Darlene Dartt is a consultant for Coopervision. Jonatan Olafsson, Xiaoran Lai, Erlend Christoffer Sommer Landsend, Eric Parissi, Reza A. Badian, and Neil Lagali have no competing interests.

Figures

**Figure 1**
Blephasteam (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) warms the eyelids by turning water in cotton rings into steam while placed over the eyes for 10 min. Figure created in Affinity Designer version 1.8 (Serif (Europe) Ltd., Nottingham, UK).

**Figure 2**
TheraPearl eye mask (Bausch & Lomb Inc., New York, USA) is preheated in a microwave before being placed on the eyelids for about 10–15 min. Figure created in Affinity Designer version 1.8 (Serif (Europe) Ltd., Nottingham, UK).

**Figure 3**
Patient inclusion, treatment allocation, and dropout. Figure created in PowerPoint version 16.53 (Microsoft, Washington, USA).

**Figure 4**
Compliance calculated as the average number of days per week that the patients were using the treatment. Smoothed conditional mean compliance were fitted using loess method for each treatment. 95% confidence bands were shown as shaded ribbon in respective colors. Figure created in R version 4.0 with ggplot2 package, version 3.3.5 (The R Foundation for Statistical Computing, Welthandelsplatz 1, 1020 Vienna, Austria).

See this image and copyright information in PMC

References

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1. Nelson JD, Shimazaki J, Benitez-del-Castillo JM, et al. The international workshop on meibomian gland dysfunction: Report of the definition and classification subcommittee. Invest. Ophthalmol. Vis. Sci. 2011;52(4):1930–1937. - PMC - PubMed
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TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial

Affiliations

TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial

Authors

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Abstract

Conflict of interest statement

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References

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LinkOut - more resources

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Medical