ClinicalTrials.gg
RecruitingNCT07928986PRECISEUpdated Nov 10, 2026

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

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

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
50 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Dry Eye Syndrome (DES)
  • Meibomian Gland Dysfunction (Disorder)

Keywords

  • Dry Eye
  • Cataract
  • Meibomian Gland Dysfunction
03

In context

Dry Eye Syndromes

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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, , 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, 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. 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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Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (estimated)
Target follow-up
8 Weeks
Patient registry
Yes

Groups and cohorts

  • Subjects with Dry Eye Syndrome, Meibomian Gland Dysfunction and Cataracts

    Patients who would likely benefit from having TearCare done before having cataract surgery.

    Device: Manual expression of meibomian glands after thermal eyelid therapy

Interventions

  • DeviceManual 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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Mean change/stability in Total Corneal Refractivew Power (PENTACAM)

    Comparison of objective measurement between visits.

    Time frame: 8 weeks from enrollment

  3. 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

  4. 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

  5. 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

07

Study locations

1 of 2 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07928986
Lead sponsor
Cleveland Eye Clinic
Collaborators
Sight Sciences, Inc.
Responsible party
Thomas Chester, OD (Dr. Thomas Chester, OD, Cleveland Eye Clinic) — Principal investigator
First posted
Nov 10, 2026
Start date
Sep 22, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 10, 2026

Study contacts

Erin Kus-Kreidler
Contact
ekus-kreidler@midwestvision.com
216-503-6535
Thomas Chester, OD
principal investigator · Cleveland Eye Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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