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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT06483750
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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

Key Dates

Start date
Jun 3, 2024
Status verified
May 2026
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up [ Time Frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery ]

Locations (1)

FacilityCityStateZIP
George Washington UniversityWashington D.C.District of Columbia20037

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By research site
George Washington University· Washington D.C., DC

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