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临床试验/NCT03856346
NCT03856346Unknown不适用

Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures: Calculation of a New Constant for Biometry IOL-formulas

Cantonal Hospital of St. Gallen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Refractive prediction error (measured by subjective refraction, in diopters)

研究概览

简要总结

The aim of the study is to evaluate the degree of refractive error postoperatively in combined procedures and to calculate a new constant in order to improve current state of the art biometry calculations.

详细描述

The IOL power calculation in combined phaco-vitrectomy has been performed similar to that in cataract surgery alone. In patients who undergo combined phaco-vitrectomy, deviations in refractive outcomes may be observed because of possible errors in measurement of axial length, changes in the properties of the vitreous cavity after removal of the vitreous, or intraocular tamponade. Most of the previous studies have reported variable degrees of myopic shift after phaco-vitrectomy for diabetic retinopathy, epiretinal membrane, and macular hole. Furthermore, use of intraoperative gas may increase further the risk of anterior displacement of the intraocular lens which may induce a higher myopic shift. However, these publications did not provide any quantification of the spherical deviations nor calculate any specific constant in order to improve currents state of art biometry calculations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy

排除标准

  • Sulcus fixation of the IOL, sulcus suture of the IOL, or intra-scleral IOL fixation because of intraoperative posterior capsule rupture
  • corneal disease, such as keratoconus, that interfered with refractive results
  • IOL implantation with a toric IOL or multifocal IOL
  • History of previous vitrectomy or corneal transplantation
  • Other coexisting ocular disease such as proliferative diabetic retinopathy, advanced age-related macular degeneration, uveitis, acute retinal necrosis, Coat's disease, proliferative vitreous retinopathy, or trauma
  • Intraocular tamponade using silicon oil

结局指标

主要结局

Refractive prediction error (measured by subjective refraction, in diopters)

时间窗: 6 weeks postoperatively

postoperative actual subjective refraction minus preoperative planned refraction in spherical equivalence (in diopters)

Absolute prediction error (measured by subjective refraction, in diopters)

时间窗: 6 weeks postoperatively

absolute value of the difference between postoperative actual refraction and preoperative planned refraction (in diopters)

Changes in Axial Length (measured by biometry, in milimeters)

时间窗: 6 weeks postoperatively

Change of axial length postoperatively (in milimeter)

Changes in corneal curvature (measured by corneal topography, in diopters)

时间窗: 6 weeks postoperatively

change in corneal curvature (in diopters)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josef Guber

Consultant ophthalmic surgeon

Cantonal Hospital of St. Gallen

研究点 (1)

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