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

NCT06483750 | Completed Results 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)

• Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

  Lipid layer thickness (LLT) was measured using LipiView II and reported in nanometers (nm). Higher values indicate a thicker lipid layer and improved tear film stability. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Change was calculated as the value at 4 weeks post-operatively minus the value at baseline. Negative values indicate a decrease from baseline.

  Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

Secondary Outcomes (3)

• Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

  Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

• Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

  Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

• Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

  Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

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

Limitations and Caveats

The sample size was relatively small, which may limit the statistical power and generalizability of the findings. Additionally, the follow up period was limited. Future studies with a larger cohort and a longer follow up duration would be beneficial to better evaluate the durability of treatment effects. Incorporating multiple follow up assessments at additional time points would also help characterize the temporal response to treatment and determine whether improvements in ocular surface parame

Results Point of Contact

• Title: Arnold Leigh
• Organization: George Washington University SMHS

arnold.leigh@gwu.edu

703-967-0226

Study Officials

• Keith Wroblewski, MD

  George Washington MFA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)