Trials / Completed
CompletedNCT06483750
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- George Washington University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-06-03
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2024-07-03
- Last updated
- 2026-02-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06483750. Inclusion in this directory is not an endorsement.