ReclutandoNCT07928986Registro de ClinicalTrials.gov

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

Dry Eye Syndrome (DES) · Meibomian Gland Dysfunction (Disorder)

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: 50 años - 75 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 36 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Población del estudio

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

Subjects with Dry Eye Syndrome, Meibomian Gland Dysfunction and Cataracts

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

Device: Manual expression of meibomian glands after thermal eyelid therapy

Manual expression of meibomian glands after thermal eyelid therapy DEVICE

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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

Plazo: 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.