A Study to Evaluate the Effectiveness of Using the Heated Eye Pad and Scorpion-1 Touch on Meibomian Gland Dysfunction
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-005309
Sponsor Protocol Number: 19-005309
About this study
The purpose of this study is to evaluate the effectiveness of using the Heated Eye Pad and Scorpion-1 Touch to Treat Patients with dry eye symptoms.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 36 participants with evidence of Meibomian Gland (MG) obstruction, based on total Meibomian glands of ≤12 in lower eye lids for each eye will be recruited.
- Assessment of Meibomian gland obstruction will be conducted by a clinician not involved in the treatment or randomization procedure.
- Participants must have a positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit.
- Participants must have a tear break up time < 10 seconds.
- Participants must agree and have the ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (Ocular lubricants are allowed if no changes are made during the study).
- Participants must be of age 18 years and older.
- Any gender or race.
- Willingness and ability to provide written informed consent to participate in the study.
- Willingness and ability to return for all study visits.
Exclusion Criteria:
- Participants will be excluded if they are taking systemic medications with tetracyclin derivatives, antihistamines, isotretinoin or nutritional supplements for MGD that started < 3 months before baseline examination.
- Participants are excluded if they are taking topical cyclosporine-A or steroids that started < 1 month before baseline examination.
- Any participant with ocular surgery or trauma < 3 months before baseline examination will be excluded.
- Participants will be excluded based on the following factors: any eyelid abnormalities, systemic diseases resulting in dry eye, individuals that were treated with LipiFlow in either eye in the last 24 months, individuals using another ophthalmic investigation device or agent within 30 days of study participation, individuals who are unable to complete the required patient questionnaires in English.
- Additionally excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Joanne Shen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available