Status:
COMPLETED
Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Aier Eye Hospital, Wuhan
Conditions:
MGD-Meibomian Gland Dysfunction
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent th...
Eligibility Criteria
Inclusion
- Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance
- A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6
- Tear breakup time (TBUT) of ≤10 s in the studied eye
- Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s)
- Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.
Exclusion
- Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment
- Facial IPL treatment within the prior 12 months
- Any surgery of the eye or eyelids within the prior six months
- Ocular surface and eyelid abnormalities
- Any systemic condition that might cause eye dryness
- Use of photosensitive drugs within the prior three months
- Precancerous lesions
- Skin cancer or pigmented lesions in the treatment area
- Overexposure to the sun within the previous month
- Ocular infections within the previous six months
- Uncontrolled infections or immunosuppressive diseases
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06034626
Start Date
November 3 2020
End Date
December 15 2021
Last Update
September 13 2023
Active Locations (3)
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1
Hankou Aier Eye Hospital, Wuhan，Hubei Province
Wuhan, Hubei, China, 430000
2
Wuhan Aier Eye Hospital, Wuhan，Hubei Province
Wuhan, Hubei, China, 430000
3
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000