Intense Pulsed Light Study for Dry Eye Disease
Completed · Not applicable · Has a placebo group
Conditions studied: Dry Eyes Chronic
In brief
This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment of dry eye disease. One eye of the participant will be randomized to receive the IPL treatment.
Key facts
- Study ID
- NCT03089580
- Run by
- University of Michigan
- People needed
- 14
- Starts
- 2017-03-25
- Expected to finish
- 2018-11-01
- Last updated by the study team
- 2019-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide informed consent;
- Diagnosed with evaporative dry eye disease with symptoms for 6 months or more;
- Able and willing to comply with follow-up visits, phone calls and intense pulsed light treatments;
- Agree to using an effective method of birth control during the course of the study;
- Agree to continue current dry eye treatments during the course of the study;
- Fitzpatrick skin scale of 1 (very fair) to 4 (olive) as determined by an investigator.
You may not qualify if…
- Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by an investigator;
- Neurotrophic keratitis;
- Ectropion, trauma, or any other lid abnormalities;
- Previous diagnosis of Stevens Johnson syndrome or graft versus host disease;
- Ocular burn, active ocular infection, or active ocular inflammation;
- Currently pregnant or trying to become pregnant in the next 5 months;
- Systemic conditions or currently taking medications which makes light therapy contraindicated (the use of doxycycline is allowed);
- Tattoos in the treatment area;
- Patients who have had intense pulsed light therapy, Lipiflow or Meibothermoflo within the past six months;
- Contact lens wear more than one time/week or history of refractive surgery;
- Glaucoma drop use
- Ophthalmic steroid use within the past 30 days;
- Punctal plugs if instilled within 30 days of the start of the study;
- Obvious asymmetry between the two eyes deemed significant by the investigators (such as punctal plugs or cautery in only one eye, etc);
- History of a trabeculectomy or tube surgery;
- Uncontrolled ocular or systemic disease;
- Ocular or eyelid surgery within the last 6 months;
- Any condition which leads the investigator to believe that the patient cannot comply with the study requirements and/or the patient may be placed at risk with participation.
Where it is running
- University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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