NCT05168670

Safety of Tinted Soft Scleral Eye Shields When IPL is Applied on Eyelids

Safety of Tinted Soft Scleral Eye Shields When IPL is Applied Directly on Eyelids of Subjects With Dry Eye Disease Due to Meibomian Gland Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 22 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the safety of tinted soft scleral eye shields when IPL is applied directly on eyelids.

Detailed description

Patients with dry eye disease due to meibomian gland dysfunction will be treated with one session of IPL applied directly on upper and lower eyelids, when eyes are protected with tinted soft scleral eye shields which prevent IPL from penetrating into ocular structures. Ocular structures will be examined with various tests (including: biomicroscopy, OCT and specular microscopy) at baseline and at 10 minutes after IPL, 24 hours after IPL, and 7 days after IPL. In addition, visual acuity will be measured at each of these times, and the patient will report of any visual symptoms at each of these times. The primary objective is to verify that no morphological or functional changes occur between the baseline and the 7 days follow-up visit.

Conditions

• Dry Eye Disease
• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Protection of eyes with tinted soft scleral eye shields	In subjects with dry eye disease due to meibomian gland dysfunction, protection of eyes with tinted soft scleral eye shields followed by IPL administration on eyelids

Timeline

• Start date: 2021-12-21
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2021-12-23
• Last updated: 2022-05-26

Locations

1 site across 1 country: United States