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临床试验/NCT07481487
NCT07481487招募中不适用

Outcomes of Cataract & Refractive Procedures

Vision Care Collective Limited1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Post-operative Uncorrected Distance Visual Acuity

研究概览

简要总结

The primary objective of the database is to retrospectively analyse the visual and refractive outcomes of cataract and refractive procedures in order to continuously assess outcomes and also compare outcomes between the different IOLs, or the different refractive procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who have undergone a refractive procedure
  • Adult patients who have undergone a cataract procedure with implantation of an intraocular lens
  • Age ≥ 18 years old
  • Patient able to consent for their pseudonymised data to be used for research purposes

排除标准

  • 未提供

研究组 & 干预措施

Patient of the clinic

The population for the database will be existing patients of the clinic. These are patients who presented to the clinic with an interest for a refractive or cataract procedure.

结局指标

主要结局

Post-operative Uncorrected Distance Visual Acuity

时间窗: postoperative visit 3-6 months

Post-operative Distance Corrected Visual Acuity

时间窗: postoperative visit 3-6 months

Post-operative subjective refraction (Sphere, Cylinder, Axis)

时间窗: postoperative visit 3-6 months

Accuracy of post-operative refraction achieved compared to targeted refraction

时间窗: postoperative visit 3-6 months

Loss of best-corrected visual acuity compared to preoperatively

时间窗: postoperative visit 3-6 months

Occurrence of surgical complications and post-operative complications

时间窗: postoperative visit 3-6 months

Post-operative Uncorrected Near Visual Acuity

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Post-operative Uncorrected Intermediate Visual Acuity

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Post-operative Distance Corrected Near Visual Acuity

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Post-operative Distance Corrected Intermediate Visual Acuity

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Defocus Curve

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Quality of Vision Questionnaire

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Contrast Sensitivity

时间窗: postoperative visit 3-6 months

For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

次要结局

  • Comparative analysis - Different types of IOLs(postoperative visit 3-6 months)
  • Comparative analysis - Refractive procedure(postoperative visit 3-6 months)

研究者

发起方
Vision Care Collective Limited
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kieren Darcy

BM MRCS (Eng) CertLRS FRCOphth MBA

Vision Care Collective Limited

研究点 (1)

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