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NCT03194698 · ClinicalTrials.gov registry record · NA
Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea
A NA study of Dry Eye and Ocular Rosacea, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03194698: Completed NA study of Dry Eye and Ocular Rosacea, sponsored by Mayo Clinic.
NCT03194698 is a NA study of Dry Eye and Ocular Rosacea that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194698, a NA study of Dry Eye and Ocular Rosacea, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Meibomian gland dysfunction (MGD) is the leading cause of evaporative dry eye and contributes to aqueous deficient dry eye. The goal of MGD therapy is to provide long term improvement of symptoms for patients by improving the quality of meibum, increasing meibum flow, improving tear film stability and decreasing inflammation. Commonly used therapies include preservative free drops, omega-3 fatty acid supplementation, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline, moisture chambers, intraductal probing, lib margin exfoliation, automated thermal pulsation, warm compresses, among other. Despite this variety of symptoms, patients often do not experience complete or long term relief of symptoms. Forced meibomian gland expression (MGX) has been shown to be an effective method of rehabilitating meibomian glands and improving dry eye symptoms. The eyelid margins are forcefully compressed to express gland contents. Research has shown improvement in patient symptoms with the use of MGX. Intense pulsed light (IPL) have been used in dermatology to treat various conditions. Patients with DED who have tried other therapies and found no relief, often resort to IPL as a last resort. Research has shown IPL alone may be effective in improving patient symptoms. In addition, such studies have failed to show significant adverse events with the use of IPL. Here, we propose a prospective, randomized, case controlled clinical pilot study to examine the efficacy for both subjective and objective measures. 20 patients with DED will be recruited and will be randomly assigned to one of two groups: MGX alone or MGX with IPL. Objective measures will include tear cytokine l
Primary Outcome
Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to
Conditions Studied
Interventions
- DEVICE Intense Pulsed Light Treatment (IPL)
- PROCEDURE Meibomian Gland Expression
Study Locations (1)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2018-12-06 |
| Phase | NA |
What the finished NCT03194698 record still lists
NCT03194698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which Intense Pulsed Light Treatment (IPL) is the first listed.
NCT03194698 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03194698 about?
NCT03194698 is a clinical study titled "Efficacy of IPL Treatment of Dry Eye and Ocular Rosacea". Dry eye disease (DED) is a common condition that causes ocular discomfort and reduces visual acuity. The two categories of DED are evaporative dry eye and aqueous deficient dry eye. Both conditions can involve pathology of the meibomian glands, lacrimal glands, lids, tear film and surface cells. Mei...
What is the current status of trial NCT03194698?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-08-17. Estimated completion is 2018-12-06.
What conditions does trial NCT03194698 study?
This clinical trial studies the following conditions: Dry Eye, Ocular Rosacea.
What interventions are being tested in trial NCT03194698?
The interventions under investigation include: Intense Pulsed Light Treatment (IPL) (DEVICE), Meibomian Gland Expression (PROCEDURE).
Who is sponsoring clinical trial NCT03194698?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03194698 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03194698's enrollment target sits among peer trials
20 35th of 41 higher than 4 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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