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

2026年11月5日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

36

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Florida
      • Largo、Florida、美国、33770
        • 尚未招聘
        • The Eye Institute of West Florida
        • 接触:
        • 副研究员:
          • Neel R Desai, MD
    • Ohio
      • Brecksville、Ohio、美国、44141
        • 招聘中
        • Cleveland Eye Clinic
        • 首席研究员:
          • Thomas Chester, OD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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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学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Mean change/stability in Keratomentry (Tmax) from baseline and at 2, 4, 6 and 8 weeks
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间:8 weeks from enrollment

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

8 weeks from enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Thomas Chester, OD、Cleveland Eye Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月22日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • TC-2026-TearCare

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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