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

NCT ID: NCT05168670

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-21
• Study Completion Date: 2022-01-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Protection of eyes with tinted soft scleral eye shields followed by IPL administration directly on eyelids

Group Type: EXPERIMENTAL

Protection of eyes with tinted soft scleral eye shields

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

IPL adminstration on eyelids

Eligibility Criteria

Inclusion Criteria

• Subject is able to read, understand and sign an IC form
• 22 or older
• Self-assessed symptoms are consistent with dry eye (SPEED score ≥ 10)
• Signs of MGD, as detected in biomicroscopy
• Fitzpatrick skin type I-V
• Subject is willing to comply with all study procedures, including return to the clinic 1 day and 1 week after the first and only treatment within the scope of the study

Exclusion Criteria

• • Fitzpatrick skin type VI

• Ocular surgery or eyelid surgery, within 3 months prior to screening
• Recent ocular trauma, within 3 months prior to screening
• Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
• Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
• Uncontrolled infections or uncontrolled immunosuppressive diseases
• Subjects with ocular infections requiring the use of antibiotic treatment, within 3 months prior to screening
• Legally blind in either eye
• Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., keratoconus, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, prior chemical burn)
• Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
• Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria
• Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
• Over exposure to sun, within 4 weeks prior to screening
• Moderate to severely compromised corneal health as assessed by corneal fluorescein staining
• Trans-illumination defects
• Anisocoria or pupil deformation
• Anterior chamber inflammation
• Media opacities (cataract, posterior capsule opacification, corneal edema, etc.) that preclude clear visualization of the anterior segment and retina
• Any condition revealed whereby the investigator deems the subject inappropriate for this study

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolando Toyos, MD

Role: PRINCIPAL_INVESTIGATOR

Toyos Clinic (Nashville, TN, USA)

Locations

Toyos Clinic

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

LUM-VBU-OPT-21-02

Identifier Type: -

Identifier Source: org_study_id