An observational study in Dry Eye Syndrome (DES) and Meibomian Gland Dysfunction (Disorder), sponsored by Cleveland Eye Clinic. Recruiting at 2 sites in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Cleveland Eye Clinic · Observational
The goal of this study is to evaluate whether TearCare treatment stabilizes corneal measurements sufficiently to determine when cataract biometry can be considered reliable.
Dry eye disease (DED), particularly meibomian gland dysfunction (MGD)-driven DED, is highly prevalent in the cataract-age population and significantly impacts the accuracy and repeatability of pre-operative corneal measurements. Instability of the tear film may result in variability in keratometry, corneal topography, higher order aberrations (HOA), and intraocular lens (IOL) power calculations.
The TearCare System is an in-oAice therapeutic system designed to treat MGD through localized thermal eyelid therapy followed by gland expression cleared. Improving tear film stability may enhance corneal measurement reliability and help determine the appropriate timing for cataract surgery planning.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 36 is below the median of 89 across 190 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Cleveland Eye Clinic as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from PIs clinic patients who are interested in participating
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Use of:
Any of the following dry eye treatments:
17. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation 18. Systemic diseases, in the Investigator's medical judgement, resulting in dry eye (e.g. diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) 19. Subject is currently using Retin A /Retin A derivatives. 20. Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.
21. Subject is currently using Latisse, Lash Boost or any other type of eyelash growth serum. Prostaglandin analog products such as Latisse should not be used within 30 days of the Screening visit.
22. Temporary false eyelashes, lash extensions, or any other type of false eyelash within 15 days of the Screening Visit.
23. Allergies to silicone tissue adhesives, acrylates and/or copper. 24. Subject has a pacemaker or implantable cardiac defibrillators (ICD). 25. Co-existing condition, either ocular or non-ocular that, in the judgement of the Investigator could aAect the safety or eAectiveness of treatment or the compliance of the subject to the protocol.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who would likely benefit from having TearCare done before having cataract surgery.
Device: Manual expression of meibomian glands after thermal eyelid therapy
In this study the TearCare procedure and system is being used to provide thermal eyelid therapy before manual expression by the PI.
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
Stability is defined as less than or equal to 0.25D difference between post-TearCare visits at 2, 4 or 6 weeks.
Time frame: 8 weeks from enrollment.
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
Stability is defined as less than or equal to 0.25D between visits
Time frame: 8 weeks from enrollment
Mean change/stability in Total Corneal Refractivew Power (PENTACAM)
Comparison of objective measurement between visits.
Time frame: 8 weeks from enrollment
Mean change in: SPEED score, OSDI score, Corneal staining (Oxford Scale), TBUT and HOA (central 4mm zone)
Comparison of subjective and objective measurements between visits.
Time frame: 8 weeks from enrollment
Percentage of patients demonstrating improvement in SPEED and OSDI
How much improvement in dry eye symptoms are people feeling, subjectively
Time frame: 8 weeks from enrollment
Determination of earliest timepoint at which corneal and IOL calculations stabilize
Determination of when it is possible to see stabilization of cornea and calculations between visits.
Time frame: 8 weeks from enrollment
Plan to share: No — All of the enpoints of the study are looking only at mean/average for all points that are being analysed, there shouldn't be a need to share individual participant data.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.