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

5. november 2026 opdateret af: Thomas Chester, OD, Cleveland Eye Clinic

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

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

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

36

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Florida
      • Largo, Florida, Forenede Stater, 33770
        • Ikke rekrutterer endnu
        • The Eye Institute of West Florida
        • Kontakt:
        • Underforsker:
          • Neel R Desai, MD
    • Ohio
      • Brecksville, Ohio, Forenede Stater, 44141
        • Rekruttering
        • Cleveland Eye Clinic
        • Ledende efterforsker:
          • Thomas Chester, OD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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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Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Subjects with Dry Eye Syndrome, Meibomian Gland Dysfunction and Cataracts

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

In this study the TearCare procedure and system is being used to provide thermal eyelid therapy before manual expression by the PI.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
Tidsramme: 8 weeks from enrollment.

Stability is defined as less than or equal to 0.25D difference between post-TearCare visits at 2, 4 or 6 weeks.

8 weeks from enrollment.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
Tidsramme: 8 weeks from enrollment

Stability is defined as less than or equal to 0.25D between visits

8 weeks from enrollment
Mean change/stability in Total Corneal Refractivew Power (PENTACAM)
Tidsramme: 8 weeks from enrollment

Comparison of objective measurement between visits.

8 weeks from enrollment
Mean change in: SPEED score, OSDI score, Corneal staining (Oxford Scale), TBUT and HOA (central 4mm zone)
Tidsramme: 8 weeks from enrollment

Comparison of subjective and objective measurements between visits.

8 weeks from enrollment
Percentage of patients demonstrating improvement in SPEED and OSDI
Tidsramme: 8 weeks from enrollment

How much improvement in dry eye symptoms are people feeling, subjectively

8 weeks from enrollment
Determination of earliest timepoint at which corneal and IOL calculations stabilize
Tidsramme: 8 weeks from enrollment

Determination of when it is possible to see stabilization of cornea and calculations between visits.

8 weeks from enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Thomas Chester, OD, Cleveland Eye Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. september 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

5. november 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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