Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction

NCT06483750 | Completed FDA Device

• 1 other identifier: NCR245538
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.

Conditions

Dry Eye Disease; Meibomian Gland Dysfunction; Cataract Senile; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Changed in Lipid Layer Thickness (LLT) measurement from baseline visit

  To assess improvement in tear film lipid layer by imaging through LipiView II. Thin lipid layer thickness (\<60 nm) indicates a tear film instability and therefore an increased evaporation rate, high osmolarity, and dry eye symptoms. In contrast, a thicker lipid layer thickness (\<120 nm) indicates a more stable tear film stability

  6 weeks

Secondary Outcomes (4)

• Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit

  6 weeks

• Mean change from baseline of Fluorescein Tear Break-Up Time (TBUT) from baseline visit

  6 weeks

• Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit

  6 weeks

• Change from baseline in Meibomian Gland Score (MGS)

  6 weeks

Study Arms (2)

Control: No Systane iLux Treatment

NO INTERVENTION

No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.

Systane iLux Treatment

EXPERIMENTAL

Systane iLux administration at baseline visit two weeks prior to cataract surgery.

Device: Systane iLux Treatment

Interventions

Systane iLux Treatment DEVICE

The Systane iLux is an approved thermal pulsation device to treat dry eye disease. The application of heat and compression to both eyelids melts meibum in the obstructed glands to restore the secretion and production of meibum to the eye. The Systane iLux will only be administered to the eye to undergo cataract surgery.

Systane iLux Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 at the time of informed consent
• Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
• Upcoming scheduled senile cataract surgery

You may not qualify if:

• Eyelid abnormalities
• Patients with active ocular infection, active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
• Ocular surgery within the last 6 months
• Occlusion therapy with lacrimal or punctum plugs within the last 3 months
• Patients with an ocular surface abnormality that may compromise corneal integrity
• Patients with ocular injury or trauma, chemical burns, or limbal stem cell deficiency (within prior 3 months)
• Patients with cicatricial lid margin disease
• patients with lid surface abnormalities that affect lid function in either eye; patients with aphakia
• Patients with permanent makeup or tattoos on their eyelids.
• Previous application/administration of Systane iLux or LipiFlow treatment

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Keith Wroblewski, MD

  George Washington MFA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 3, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)