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A Prospective, Comparative Study to investigate the Clinical Efficacy of iLUX and IPL treatment in Dry Eye Patients with Meibomian gland dysfunction

A Prospective, Comparative Study to investigate the Clinical Efficacy of iLUX and IPL treatment in Dry Eye Patients with Meibomian gland dysfunction

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009605
Enrollment
140
Registered
2024-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Clinical trials are conducted by performing iLUX treatment (medical device: Systane iLUX, Alcon (USA)) or IPL treatment (medical device: Lumenis IPL, Yokneam (Israel)) in both eyes fo

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who visited Asan Medical Center between IRB approval date and March 30, 2025 (3 months prior to June 30, 2025) and were diagnosed with dry eye syndrome with MGD and voluntarily agreed to participate in clinical trials. 2) Mild to moderate dry eye syndrome with MGD is diagnosed by the following criteria. i. symptoms of dry eye syndrome persist for at least 3 months before registration of clinical trial ii. The TBUT is less than 10 seconds and meets at least one of the following three criteria a. Meibomian gland secretion is reduced during eyelid compression, showing turbid, toothpaste-like secretions, or viscous secretions. b. Two or more telangiectasia at the edge of your eyelid c. Two or more orifices for meibomian gland are blocked 3) Age 19 years and older and under 85 years of any gender or race 4) Ocular surface disease index (OSDI) score of 33 or lower (mild to moderate OSDI score)

Exclusion criteria

Exclusion criteria: 1) Sjogren’s disease 2) all the orifices of the upper and lower meibomian glands are completely blocked and no secretion of meibum 3) Subject with use of cyclosporine, steroids, or antibiotics (eye drops) within 2 weeks of the screening day. 4) Subject with use of eye drops containing lipid within 2 weeks of the screening day. 5) Wearing contact lenses within the six month of screening day. 6) Ophthalmic surgery or trauma within the last 3 months of screening day. 7) Subject planning eye surgery (including LASIK/LASEK) during the study period 8) Pregnant women, lactating women and planning to pregnant women 9) Allergic to fluorescein eye drops. 10) Other things that are not suitable judged by an investigator

Design outcomes

Primary

MeasureTime frame
total Meibomian Gland Dysfunction (MGD) grade

Secondary

MeasureTime frame
Matrixmetalloproteinase-9 (MMP-9) , Tear Break Up Time

Countries

Korea, Republic of

Contacts

Public ContactHun Lee

Asan Medical Center

yhun777@amc.seoul.kr+82-2-3010-5931

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026