A Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

50 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

36 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this study is to evaluate whether TearCare treatment stabilizes corneal measurements sufficiently to determine when cataract biometry can be considered reliable.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age 50-75 years
2. Diagnosis of MGD and DED
3. OSDI score 23-79
4. TBUT \> 1 second and ≤ 7 seconds
5. MGSS \<12 in both eyes
6. ≥15 expressible meibomian glands
7. Candidate for cataract surgery planning (ie. Phakic)

Exclusion Criteria:

1. Use of:

1. Cyclosporine, Xiidra, or serum tears within 30 days prior to Screening;
2. Antihistamines (oral or topical) within 7 days prior to Screening;
3. Oral tetracyclines or azithromycin within 30 days prior to Screening;
4. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, nonsteroidal anti-inflammatory medications within 30 days prior to Screening
5. Isotretinoin (e.g. Accutane) at any time.
2. Any of the following dry eye treatments:

1. OAice-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \[LipiFlow\], iLuxetc.) within 12 months prior to Screening either as part of routine care or clinical investigation;
2. Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);
3. Meibomian gland expression within 6 months prior to Screening;
4. Blephex or debridement within 3 months prior TC-2026-TearCare, V2, 15JUN2026 Page 10 of 26 to Screening;
5. Punctal occlusion (including collagen, e.g. Soft Plug, UltraPlug, or crosslinked hyaluronic acid, e.g. Lacrifill) or punctal plugs within 15 days of the Screening visit
6. Use of tear neurostimulators (i.e., True Tear, iTear100, Tyrvaya) within 2 weeks of the baseline visit. (Subjects must refrain from using tear neurostimulators for the duration of the study)
7. Any history of meibomian gland probing.
3. History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.
4. Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
5. Contact lens use within 2 weeks of the Procedure visit. Subjects presenting at the Screening visit using contact lenses must agree to discontinue use for a full 2 weeks (14 days) prior to the Procedure Visit.
6. Active hordeolum, stye, or chalazion at the time of the Screening visit
7. History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
8. Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation based on Investigator's judgement.
9. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to screening based on Investigator's judgement.
10. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
12. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area based on Investigator's judgement.
13. In the clinical judgement of the Investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a cotton swab. TC-2026-TearCare, V2, 15JUN2026 Page 11 of 26
14. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis. 16. Ocular trauma within 3 months prior to Screening.

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. autoimmune 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.

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Study population

Subjects will be recruited from PIs clinic patients who are interested in participating

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Cleveland Eye Clinic

Study start

Sep 22, 2026 Actual

Primary completion

2026-12 Estimated

Study completion

2026-12 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts