A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice (NCT03708367) | Clinical Trial Compass
CompletedNot Applicable
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
United States117 participantsStarted 2018-10-16
Plain-language summary
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (all criteria apply to each study eye):
* Minimum 22 years of age.
* Bilateral cataracts for which phacoemulsification extraction and implantation with Symfony IOLs have been planned.
* Evidence of Meibomian Gland Dysfunction (MGD) in both eyes based on assessment of meibomian glands of the lower eyelid
* None to moderate dry eye symptoms with questionnaire
* Clear intraocular media other than cataract in each eye.
* Availability, willingness, ability and sufficient cognitive awareness to comply with the study protocol including: randomization; examination procedures; completion of planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye treatments.
* Ability to understand, read and write English to consent to study participation and complete study questionnaires.
* Willingness to sign informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing country.
Exclusion Criteria (all criteria apply to each study eye):
* Any medical finding that would predictably result in a postoperative best corrected distance visual acuity worse than 20/30 in either eye.
* Use of systemic or ocular medications that, in the opinion of the investigator, may affect vision or impact pupil dilation or iris structure.
* Irregular corneal astigmatism.
* Any clinically-significant corneal pathology / abnormality other than regular corneal astigmatism.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
Timeframe: 3 months Postoperative
2
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Timeframe: 2-4 weeks after first Pre-operative visit
3
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Timeframe: 2-4 weeks after first Pre-operative visit
4
Rate of Refractive Predictability
Timeframe: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.
5
Rate of Bothersome Ocular Symptoms
Timeframe: 3 months postoperative
6
Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
Timeframe: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.