N/A N=30 Randomized Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT06483750 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up — -1.9; 19.5 Nanometers

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Systane iLux Treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: George Washington University
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up	-1.9; 19.5	—
SECONDARY Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up	0.6; -3.4	—
SECONDARY Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up	-0.1; -11.8	—
SECONDARY Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up	0.21; -0.27	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06483750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.