A Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery (PRECISE)
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Erin Kus-Kreidler
- Telefonní číslo: 216-503-6535
- E-mail: ekus-kreidler@midwestvision.com
Studijní místa
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Florida
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Largo, Florida, Spojené státy, 33770
- Zatím nenabíráme
- The Eye Institute of West Florida
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Kontakt:
- Renee Bondurant
- Telefonní číslo: 727-581-8706
- E-mail: renee.bondurant@eyespecialist.com
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Dílčí vyšetřovatel:
- Neel R Desai, MD
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Ohio
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Brecksville, Ohio, Spojené státy, 44141
- Nábor
- Cleveland Eye Clinic
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Vrchní vyšetřovatel:
- Thomas Chester, OD
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Kontakt:
- Erin Kus-Kreidler
- Telefonní číslo: 216-503-6535
- E-mail: ekus-kreidler@midwestvision.com
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Subjects will be recruited from PIs clinic patients who are interested in participating
Popis
Inclusion Criteria:
- Age 50-75 years
- Diagnosis of MGD and DED
- OSDI score 23-79
- TBUT > 1 second and ≤ 7 seconds
- MGSS <12 in both eyes
- ≥15 expressible meibomian glands
- Candidate for cataract surgery planning (ie. Phakic)
Exclusion Criteria:
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Use of:
- Cyclosporine, Xiidra, or serum tears within 30 days prior to Screening;
- Antihistamines (oral or topical) within 7 days prior to Screening;
- Oral tetracyclines or azithromycin within 30 days prior to Screening;
- Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, nonsteroidal anti-inflammatory medications within 30 days prior to Screening
- Isotretinoin (e.g. Accutane) at any time.
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Any of the following dry eye treatments:
- 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;
- Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);
- Meibomian gland expression within 6 months prior to Screening;
- Blephex or debridement within 3 months prior TC-2026-TearCare, V2, 15JUN2026 Page 10 of 26 to Screening;
- 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
- 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)
- Any history of meibomian gland probing.
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History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.
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Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
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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.
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Active hordeolum, stye, or chalazion at the time of the Screening visit
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History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
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Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation based on Investigator's judgement.
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Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to screening based on Investigator's judgement.
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Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
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Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
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Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area based on Investigator's judgement.
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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
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Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
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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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Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Počet skupin / kohort
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
Časové okno: 8 weeks from enrollment.
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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.
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
Časové okno: 8 weeks from enrollment
|
Stability is defined as less than or equal to 0.25D between visits |
8 weeks from enrollment
|
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Mean change/stability in Total Corneal Refractivew Power (PENTACAM)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 8 weeks from enrollment
|
Determination of when it is possible to see stabilization of cornea and calculations between visits. |
8 weeks from enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas Chester, OD, Cleveland Eye Clinic
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- TC-2026-TearCare
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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