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

5 november 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

36

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Florida
      • Largo, Florida, Förenta staterna, 33770
        • Har inte rekryterat ännu
        • The Eye Institute of West Florida
        • Kontakt:
        • Underutredare:
          • Neel R Desai, MD
    • Ohio
      • Brecksville, Ohio, Förenta staterna, 44141
        • Rekrytering
        • Cleveland Eye Clinic
        • Huvudutredare:
          • Thomas Chester, OD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 8 weeks from enrollment

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

8 weeks from enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Thomas Chester, OD, Cleveland Eye Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 september 2026

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

5 november 2026

Först inskickad som uppfyllde QC-kriterierna

5 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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