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

The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Cataract Senile; Meibomian Gland Dysfunction; Dry Eye Disease
• Intervention / Treatment: Device: Systane iLux Treatment

Detailed Description

Eligible patients to be recruited will have scheduled upcoming senile cataract surgery. Enrolled patients in the active arm (n=25) will receive pre-operative Systane iLux treatment two weeks prior to surgery at the baseline visit. Patients in the control arm will receive no Systane iLux treatment at the baseline visit two weeks prior to cataract surgery. Patients will be assessed on baseline metrics for dry eye disease stemming and meibomian gland dysfunction (MGD) at the baseline visit two weeks prior to cataract surgery. These metrics include tear break up time (TBUT), standard patient evaluation of eye dryness questionnaire (SPEED), ocular surface and surface disease index (OSDI) surveys, and lipid layer thickness (LLT). At the follow up visit four weeks after cataract surgery, these same metrics will be assessed again for any significant changes.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control: No Systane iLux Treatment; No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.
Experimental: Systane iLux Treatment; Systane iLux administration at baseline visit two weeks prior to cataract surgery.	Device: Systane iLux Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up	The SPEED questionnaire assesses dry eye symptom severity on a scale from 0 to 64, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.	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	The OSDI questionnaire assesses dry eye symptom severity on a scale from 0 to 100, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.	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	Meibomian gland morphology was assessed using infrared meibography with the LipiView II system. Gland dropout was graded on a standardized ordinal scale from 0 to 3 (0 = no gland loss; 3 = >66% gland loss), with higher scores indicating greater structural gland loss. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Analyses were conducted at the participant level. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Positive values indicate worsening gland loss.	Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Keith Wroblewski, MD, George Washington MFA

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes
• Other Study ID Numbers: NCR245538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes