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临床试验/NCT05392738
NCT05392738
Unknown
不适用

Visual Function and Patient Satisfaction in Glaucoma or Ocular Hypertensive Patients Undergoing Simultaneous Cataract Surgery and i-Stent Implantation

Clínica Rementería1 个研究点 分布在 1 个国家目标入组 45 人2022年6月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Lenses, Intraocular
发起方
Clínica Rementería
入组人数
45
试验地点
1
主要终点
Binocular uncorrected near visual acuity
最后更新
3年前

概览

简要总结

New extended depth of focus intraocular lenses (IOLs) are being used in a broader spectrum of patients than trifocal IOLs. The purpose of this study is to evaluate visual improvement after cataract surgery in patients with glaucoma or ocular hypertension undergoing simultaneous cataract surgery with i-Stent implantation with the implantation of a Vivity IOL. Results will be compared with a group of glaucoma or ocular hypertension undergoing isolated cataract surgery with Vivity implantation, as well as with patients with no pathology undergoing cataract surgery and Vivity implantation

详细描述

The purpose of this study is to report in detail visual function and patient satisfaction, as well as the need for spectacle correction, in patients with glaucoma and ocular hypertension undergoing cataract surgery with bilateral implantation of an extended depth of focus IOL, the Vivity IOL. The study also seeks to determine if there are differences in the speed of visual improvement between patients undergoing isolated cataract surgery and patients undergoing simultaneous i-Stent implantation. Results will also be compared with a group of patients with no ocular pathology undergoing cataract surgery with Vivity implantation. Patients will be asked to join the study once the type of surgery (isolated phacoemulsification versus phacoemulsification combined with i-Stent implantation) and the type of lens to be implanted (monofocal, EDoF, trifocal) has been agreed between ophthalmologist and patient. Therefore, inclusion in the study will have no influence on surgical indication. Once informed consent has been signed, the patient will be included in the study. Explorations specific for the study will be performed 3 and 12 months after surgery and include: Defocus curves Contrast sensitivity Self-reported photic phenomena Need for spectacle correction Satisfaction measured with the Catquest SF9 questionnaire Besides study-specific procedures, the following explorations which are standard of care will be performed one day, one week and one month after surgery: Uncorrected binocular visual acuity for distance, intermediate and near distances Monocular distance corrected and uncorrected visual acuity Residual subjective refraction Slit-lamp examination Intraocular pressure and number of hypotensive drugs required Description of any intra- or postsurgical complications

注册库
clinicaltrials.gov
开始日期
2022年6月20日
结束日期
2024年6月
最后更新
3年前
研究类型
Observational
性别
All

研究者

发起方
Clínica Rementería
责任方
Sponsor

入排标准

入选标准

  • Bilateral cataract surgery with Vivity implantation with or without i_STent implantation

排除标准

  • Ocular disease other than glaucoma

结局指标

主要结局

Binocular uncorrected near visual acuity

时间窗: Three months after surgery

Binocular uncorrected near visual acuity

Binocular uncorrected distance visual acuity

时间窗: Three months after surgery

Binocular uncorrected distance visual acuity

Binocular uncorrected intermediate visual acuity

时间窗: Three months after surgery

Binocular uncorrected intermediate visual acuity

次要结局

  • Binocular uncorrected distance visual acuity(One month after surgery)
  • Need for spectacle correction(Three months after surgery)
  • Binocular uncorrected near visual acuity(One month after surgery)
  • Binocular uncorrected intermediate visual acuity(One month after surgery)
  • Contrast sensitivity(Three months after surgery)
  • Patient satisfaction(Three months after surgery)

研究点 (1)

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