- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Erin Kus-Kreidler
- Telefonszám: 216-503-6535
- E-mail: ekus-kreidler@midwestvision.com
Tanulmányi helyek
-
-
Florida
-
Largo, Florida, Egyesült Államok, 33770
- Még nincs toborzás
- The Eye Institute of West Florida
-
Kapcsolatba lépni:
- Renee Bondurant
- Telefonszám: 727-581-8706
- E-mail: renee.bondurant@eyespecialist.com
-
Alkutató:
- Neel R Desai, MD
-
-
Ohio
-
Brecksville, Ohio, Egyesült Államok, 44141
- Toborzás
- Cleveland Eye Clinic
-
Kutatásvezető:
- Thomas Chester, OD
-
Kapcsolatba lépni:
- Erin Kus-Kreidler
- Telefonszám: 216-503-6535
- E-mail: ekus-kreidler@midwestvision.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Subjects will be recruited from PIs clinic patients who are interested in participating
Leírás
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.
-
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.
-
Active hordeolum, stye, or chalazion at the time of the Screening visit
-
History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
-
Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation based on Investigator's judgement.
-
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
-
Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea
-
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.
-
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 8 weeks from enrollment
|
Determination of when it is possible to see stabilization of cornea and calculations between visits. |
8 weeks from enrollment
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Thomas Chester, OD, Cleveland Eye Clinic
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- TC-2026-TearCare
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
az Egyesült Államokban gyártott és onnan exportált termék
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .