NCT02621593

Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD

Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.

Detailed description

The IPL module has FDA clearance (K142860) for a wide range of indications, including benign cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains, pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy administered close to the ocular orbits is safe (provided that the eyes are shielded). However, the above mentioned study was retrospective. Therefore, additional evidence is needed in order to substantiate the hypothesis that alleviation of MGD symptom was facilitated by IPL treatments. The aim of the current study is to assess the safety and efficacy of IPL treatment for reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant increase in tear break-up time post-treatment, compared to pre-treatment.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	M22-IPL	The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-12-03
• Last updated: 2017-02-02

Locations

2 sites across 1 country: United States