Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
NCT ID: NCT06034626
Last Updated: 2023-09-13
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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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2020-11-03
2021-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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OPL-I
Patients treated with OPL-I with the dual filter system
Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
M22
Patients treated with OPL-I with the single filter system
Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Interventions
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Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Eligibility Criteria
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Inclusion Criteria
2. A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6
3. Tear breakup time (TBUT) of ≤10 s in the studied eye
4. Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s)
5. Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.
Exclusion Criteria
2. Facial IPL treatment within the prior 12 months
3. Any surgery of the eye or eyelids within the prior six months
4. Ocular surface and eyelid abnormalities
5. Any systemic condition that might cause eye dryness
6. Use of photosensitive drugs within the prior three months
7. Precancerous lesions
8. Skin cancer or pigmented lesions in the treatment area
9. Overexposure to the sun within the previous month
10. Ocular infections within the previous six months
11. Uncontrolled infections or immunosuppressive diseases
18 Years
75 Years
ALL
No
Sponsors
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Aier Eye Hospital, Wuhan
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Xiuming Jin, PhD
Role: STUDY_DIRECTOR
Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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Hankou Aier Eye Hospital, Wuhan，Hubei Province
Wuhan, Hubei, China
Wuhan Aier Eye Hospital, Wuhan，Hubei Province
Wuhan, Hubei, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.
Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, Huang X, Li J, Song W, Lin L, Cheng Y. The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Eye Contact Lens. 2021 Jan 1;47(1):45-53. doi: 10.1097/ICL.0000000000000711.
Other Identifiers
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2020-210
Identifier Type: -
Identifier Source: org_study_id
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