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

Last updated: May 14, 2026
Sponsor: George Washington University
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Dry Eye Disease

Treatment

Systane iLux Treatment

Clinical Study ID

NCT06483750
NCR245538
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Age greater than 18 at the time of informed consent

  • Must understand; be willing and able, and likely to fully comply with studyprocedures, visit schedule, and restrictions

  • Upcoming scheduled senile cataract surgery

Exclusion

Exclusion Criteria:

  • Eyelid abnormalities

  • Patients with active ocular infection, active ocular inflammation or history ofchronic, 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 celldeficiency (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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Systane iLux Treatment
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • George Washington University

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • George Washington University

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

    Site Not Available

  • George Washington University

    Washington D.C. 4140963, District of Columbia 4138106 20037
    United States

    Site Not Available

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