Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

MGD-Meibomian Gland Dysfunction Clinical Trial

— MGD  

Official title:

Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034626
• Other study ID #: 2020-210
• Status: Completed
• Phase: Phase 3
• Start date: November 3, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were followed up three to four weeks after each session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 15, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance

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:

1. Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction
• MGD-Meibomian Gland Dysfunction

Intervention

Procedure:
• Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.

Drug:
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Hankou Aier Eye Hospital, Wuhan,Hubei Province	Wuhan	Hubei
China	Wuhan Aier Eye Hospital, Wuhan,Hubei Province	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Aier Eye Hospital, Wuhan

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPEED Scores	Standard Patient Evaluation of Eye Dryness questionnaire	Baseline, 1 month, 2 months, 3 months, 4 months
Primary	CFS scores	corneal fluorescein staining scores	Baseline, 1 month, 2 months, 3 months, 4 months
Primary	TBUT	Tear breakup time	Baseline, 1 month, 2 months, 3 months, 4 months
Primary	MGSS	Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands.	Baseline, 1 month, 2 months, 3 months, 4 months
Primary	MGMS	meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum).	Baseline, 1 month, 2 months, 3 months, 4 months
Secondary	BCVA	best-corrected visual acuity	Baseline, 4 months
Secondary	IOP	intraocular pressure measurements	Baseline, 4 months