Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-05-01
2025-12-31
Brief Summary
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Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Red light only group
LLLT will be administered using the Espansione Group Ltd Eye-light unit. LLLT consisting of a wearable facial mask with red light emitting diodes (LEDs) is administered for 30 minutes.
Red LLLT
Mask with LEDs emitting at wavelengths of 633nm to facial and eyelids region with their eyes closed
Red plus blue light group
LLLT consisting of a wearable facial mask with red LEDs is administered for 15 minutes, followed by a mask with blue LEDs for another 15 minutes.
Red LLLT
Mask with LEDs emitting at wavelengths of 633nm to facial and eyelids region with their eyes closed
Blue LLLT
Mask with LEDs emitting at wavelengths of 428nm to facial and eyelid regions with their eyes closed
Sham treatment group
Sham treatment will be administered by using facial mask with red LEDs emitting at less than 10% fluence power output for 15 minutes, followed by a mask with blue LEDs emitting at less than 10% fluence power output for another 15 minutes.
Sham Red LLLT
Mask with LEDs emitting at wavelengths of 633nm, but with \<10% fluence power output, to facial and eyelids region with their eyes closed
Sham Blue LLLT
Mask with LEDs emitting at wavelengths of 428nm, but with \<10% fluence power output, to facial and eyelids region with their eyes closed
Interventions
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Red LLLT
Mask with LEDs emitting at wavelengths of 633nm to facial and eyelids region with their eyes closed
Blue LLLT
Mask with LEDs emitting at wavelengths of 428nm to facial and eyelid regions with their eyes closed
Sham Red LLLT
Mask with LEDs emitting at wavelengths of 633nm, but with \<10% fluence power output, to facial and eyelids region with their eyes closed
Sham Blue LLLT
Mask with LEDs emitting at wavelengths of 428nm, but with \<10% fluence power output, to facial and eyelids region with their eyes closed
Eligibility Criteria
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Inclusion Criteria
* Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 1 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction.
* Individuals will also need to have ocular demodicosis, diagnosed by clinical observation on slit lamp biomicroscope based on signs including collarettes around the base of lashes, visible Demodex tails, or excessive pouting of lash follicles in those with good lid hygiene where Demodex was confirmed by secondary means such as visible Demodex tails.
* Age ≥ 18 years, male or female
* Able to provide written consent in English
* Able to attend a total of 4 visits: 3 treatment visits and followed up for 1 month after final treatment
Exclusion Criteria
* Ocular light-based therapies including intense pulsed light (IPL) or LLLT treatment within the past 1 month or during study period in addition to those provided in the study
* Contact lens wear in the past 2 weeks or during study period
* Other active ocular surface diseases or history of ocular surgery or corneal infections the past 6 months
18 Years
ALL
No
Sponsors
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Aston University
OTHER
Responsible Party
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Principal Investigators
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James S Wolffsohn, PhD
Role: STUDY_DIRECTOR
Aston University
Locations
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Aston Dry Eye Clinic
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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James S Wolffsohn, PhD
Role: primary
References
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Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.
Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Chalmers RL, Begley CG, Caffery B. Validation of the 5-Item Dry Eye Questionnaire (DEQ-5): Discrimination across self-assessed severity and aqueous tear deficient dry eye diagnoses. Cont Lens Anterior Eye. 2010 Apr;33(2):55-60. doi: 10.1016/j.clae.2009.12.010. Epub 2010 Jan 25.
Arita R, Minoura I, Morishige N, Shirakawa R, Fukuoka S, Asai K, Goto T, Imanaka T, Nakamura M. Development of Definitive and Reliable Grading Scales for Meibomian Gland Dysfunction. Am J Ophthalmol. 2016 Sep;169:125-137. doi: 10.1016/j.ajo.2016.06.025. Epub 2016 Jun 23.
Other Identifiers
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HLS21156
Identifier Type: -
Identifier Source: org_study_id