Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease
NCT ID: NCT06158997
Last Updated: 2023-12-06
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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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-03
2024-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EyePeace+Heated eye mask group
Participants will received the HEM therapy for 10 minutes according to the manufacturer's instructions. This was followed immediately by 10 gentle squeezes of the eyelid massage device on one eye
EyePeace
EyePeace a commercially available for enhancing meibum expression. The flexible, handheld device is made of silicone and provides regulated vertical pressure on closed eyelids (https://www.eyepeace.de). EyePeace will be used to assess its usefulness in improving evaporative dry eye signs and symptoms.
Heated Eye Mask
Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.
Heated Eye Mask group
Participants in Heated Eye Mask group will use heated eye mask once.
Heated Eye Mask
Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.
Interventions
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EyePeace
EyePeace a commercially available for enhancing meibum expression. The flexible, handheld device is made of silicone and provides regulated vertical pressure on closed eyelids (https://www.eyepeace.de). EyePeace will be used to assess its usefulness in improving evaporative dry eye signs and symptoms.
Heated Eye Mask
Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to comply with the treatment/follow-up schedule
* Bilateral signs and symptoms of dry eye disease or MGD
Exclusion Criteria
* The eyelids or intraocular tumor unfavorable pressure
* Previous ocular surgery or trauma
* Barriers to the subjects in the research of ocular surface active allergies, infection or inflammatory bowel disease
* Intraocular pressure is less than 10 mmHg or more than 21 mmHg
* Diabetes or other eye table, healthy body, skin diseases, or diseases of the nervous system;
* Use any may interfere with tears within three months of systemic anti-inflammatory drugs or medicines, such as resistance to anxiety, depression and antihistamines
* The local administration of ophthalmology recent history (in the past 30 days) including antibiotics, steroids and non-steroidal anti-inflammatory drug, or long-term use of local ophthalmic drug
* Researchers determine patients not suitable for this study
18 Years
99 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Emmanuel Eric Pazo
Role: STUDY_CHAIR
He Eye Hospital, Shenyang, China
Locations
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He Eye Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Jun Li, M.D., Ph.D.
Role: primary
Emmanuel Eric Pazo, M.D., Ph.D.
Role: backup
References
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Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5.
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Heidari M, Noorizadeh F, Wu K, Inomata T, Mashaghi A. Dry Eye Disease: Emerging Approaches to Disease Analysis and Therapy. J Clin Med. 2019 Sep 11;8(9):1439. doi: 10.3390/jcm8091439.
Wang MTM, Feng J, Wong J, Turnbull PR, Craig JP. Randomised trial of the clinical utility of an eyelid massage device for the management of meibomian gland dysfunction. Cont Lens Anterior Eye. 2019 Dec;42(6):620-624. doi: 10.1016/j.clae.2019.07.008. Epub 2019 Jul 26.
Tichenor AA, Cox SM, Ziemanski JF, Ngo W, Karpecki PM, Nichols KK, Nichols JJ. Effect of the Bruder moist heat eye compress on contact lens discomfort in contact lens wearers: An open-label randomized clinical trial. Cont Lens Anterior Eye. 2019 Dec;42(6):625-632. doi: 10.1016/j.clae.2019.09.005. Epub 2019 Oct 3.
Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D.
Butovich IA. Lipidomics of human Meibomian gland secretions: Chemistry, biophysics, and physiological role of Meibomian lipids. Prog Lipid Res. 2011 Jul;50(3):278-301. doi: 10.1016/j.plipres.2011.03.003. Epub 2011 Mar 31.
McMonnies CW. Management of chronic habits of abnormal eye rubbing. Cont Lens Anterior Eye. 2008 Apr;31(2):95-102. doi: 10.1016/j.clae.2007.07.008. Epub 2008 Mar 19.
Zhang Q, Wu Y, Song Y, Qin G, Yang L, Talwar SS, Lin T, Talwar GDS, Zhang H, Xu L, Moore JE, Pazo EE, He W. Screening Evaporative Dry Eyes Severity Using an Infrared Image. J Ophthalmol. 2021 Aug 24;2021:8396503. doi: 10.1155/2021/8396503. eCollection 2021.
Chen J, Yu S, Qin G, Moutari S, Moore JE, Xu L, He W, Pazo EE, He X. Immediate sequential changes in the tear film lipid layer following eyelid massage in dry eye syndrome: A comparative control study. Heliyon. 2024 Aug 20;10(17):e36590. doi: 10.1016/j.heliyon.2024.e36590. eCollection 2024 Sep 15.
Other Identifiers
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DEDEP2023
Identifier Type: -
Identifier Source: org_study_id