Clinical trial Recruiting at 1 site Observational Ages 50 to 75

TearCare treatment for stable corneal measurements before cataract surgery

Official title: A Multi Center, Peri-Cataract Evaluation of TearCare With Expression on Ocular Biometry and Surgical Measurements

Run by Cleveland Eye Clinic · NCT07928986 · Data updated 2026-11-12

This study tests whether TearCare therapy followed by gland expression helps stabilize the tear film so pre-surgery measurements for cataract planning are more reliable for people with dry eye and meibomian gland dysfunction.

More Dry Eye Syndrome (DES) trials

Quick facts

Study typeObservational
Ages50 Years to 75 Years
SexAll
Enrollment36 (estimated)
SponsorCleveland Eye Clinic
Academic / other
Locations2 sites (Largo, Florida and 1 other locations)
StatusRecruiting
StartedSeptember 22, 2026
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedNovember 10, 2026
Trial IDNCT07928986 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 50-75 with diagnosed MGD and DES who are planning cataract surgery and meet specific tear film and gland criteria.

Probably not a fit

Patients whose corneal measurements remain unstable after TearCare may not experience improved biometry reliability.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study examines if TearCare treatment can stabilize keratometry, corneal topography, and other measurements used to calculate IOL power before cataract surgery. Participants have dry eye disease with meibomian gland dysfunction and are planning cataract surgery. After thermal eyelid therapy plus gland expression, corneal measurements are repeated to assess stability and potential improvement in measurement reliability. The findings could inform timing of cataract surgery and improve biometry accuracy. The study is conducted at two clinical sites with specific inclusion and exclusion criteria to reflect real-world patients.

Why it matters

Potential benefit: If TearCare helps stabilize tear film, patients may experience more reliable cataract biometry and potentially improved IOL power predictions.

How similar studies have gone: Previous tear-film stabilization approaches have shown variable improvements in measurement reliability; this study adds contemporary real-world data for TearCare.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

\-

Where it's running

  • Cleveland Eye Clinic
    Brecksville, Ohio, United States
    Recruiting
  • The Eye Institute of West Florida
    Largo, Florida, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.