Clinical utility of Quantum Molecular Resonance treatment for dry eye disease

The University of Auckland0 个研究点目标入组 58 人开始时间: 2021年9月3日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•Participants with symptomatic dry eye caused by evaporative causes (e.g. meibomian gland dysfunction) or aqueous deficient causes (e.g. Sjögren's syndrome).
•Participants will be required to:
•Meet TFOS DEWS II criteria for dry eye diagnosis
•Be willing and able to follow the protocol accurately
•Be willing to minimise application of dry eye treatments beyond the study treatment
•TFOS DEWS II dry eye diagnosis:
•Adult participants meeting the criteria for dry eye disease according to the TFOS DEWS II diagnostic criteria (symptoms: OSDI greater or equal to 13, DEQ-5 greater or equal to 6; plus one or more signs: non-invasive breakup time (NIBUT) less than 10s, osmolarity greater than 308 or interocular diff of greater or equal to 8; greater than 5 spots corneal staining with NaFl, greater than 9 spots conjunctival staining with lissamine green, lid margin staining (lid wiper epitheliopathy) of greater or equal to 2mm in length and greater or equal to 25% lid margin width will be recruited.
•Subclassification according to dry eye status (ADDE, EDE or mixed) and severity (mild-moderate vs moderate-severe) will be determined according to established cut-offs.
•For EDE: Clinically significant signs of MGD: (eyelid margin or mucocutaneous junction abnormalities, meibomian gland orifice capping, and/or decreased expressed meibum quality).
•For ADDE: reduced tear meniscus height (less than 0.2mm).

•Exclusion Criteria:
•OPAS score greater than 70% on questions 1, 4 or 7 indicating possible ocular neuropathic pain that may be unresponsive to treatment
•Contact lens wear, or application of topical therapies other than dry eye drops within two weeks of the eligibility assessment or during the trial
•Use of systemic medications known to affect the ocular surface or tear production
•Current or planned pregnancy or lactation during the study
•History of major systemic, dermatologic or ocular conditions
•Ocular surgery or dermatologic treatments in the previous three months or planned during the treatment period.
•Unwillingness to refrain from dye drop application on study visit days
•Use of warm compresses or lid hygiene unless applied regularly as part of a stable regime for greater than 3 months and continued throughout trial, but not within 24 hours of study visits
•LipiFlow, IPL (Intense Pulsed Light) or investigational treatment for dry eye disease within 6 months of study start
•Lid debridement or therapeutic meibomian gland expression within 1 month of study start

发起方