- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07928986
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.
Studieöversikt
Status
Intervention / Behandling
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
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Erin Kus-Kreidler
- Telefonnummer: 216-503-6535
- E-post: ekus-kreidler@midwestvision.com
Studieorter
-
-
Florida
-
Largo, Florida, Förenta staterna, 33770
- Har inte rekryterat ännu
- The Eye Institute of West Florida
-
Kontakt:
- Renee Bondurant
- Telefonnummer: 727-581-8706
- E-post: renee.bondurant@eyespecialist.com
-
Underutredare:
- Neel R Desai, MD
-
-
Ohio
-
Brecksville, Ohio, Förenta staterna, 44141
- Rekrytering
- Cleveland Eye Clinic
-
Huvudutredare:
- Thomas Chester, OD
-
Kontakt:
- Erin Kus-Kreidler
- Telefonnummer: 216-503-6535
- E-post: ekus-kreidler@midwestvision.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Subjects will be recruited from PIs clinic patients who are interested in participating
Beskrivning
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:
-
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.
-
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.
-
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.
-
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
-
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.
-
Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
-
Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
-
Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area based on Investigator's judgement.
-
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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Studieplan
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
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Thomas Chester, OD, Cleveland Eye Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TC-2026-TearCare
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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.
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