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临床试验/NCT05797298
NCT05797298招募中不适用

Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 3,000 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
状态
招募中
入组人数
3,000
试验地点
1
主要终点
IOL tilt at six months

研究概览

简要总结

This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

详细描述

This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • • small pupil
  • zonular dehiscence
  • preexisting corneal pathology
  • a history of ocular trauma or surgery
  • severe intraoperative and postoperative complications

结局指标

主要结局

IOL tilt at six months

时间窗: six months

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL tilt at one week

时间窗: one week

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL tilt at one year

时间窗: one year

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL tilt at one month

时间窗: one month

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL rotation degree at three months

时间窗: three months

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at one hour

时间窗: one hour

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at one week

时间窗: one week

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL tilt at two weeks

时间窗: two weeks

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL tilt at three years

时间窗: three years

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL decentration at six months

时间窗: six months

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL rotation degree at one day

时间窗: one day

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at three days

时间窗: three days

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at one year

时间窗: one year

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL decentration at three months

时间窗: three months

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL rotation degree at three years

时间窗: three years

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at two weeks

时间窗: two weeks

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at one month

时间窗: one month

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL rotation degree at six months

时间窗: six months

After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

IOL decentration at one week

时间窗: one week

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL decentration at one month

时间窗: one month

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL tilt at three months

时间窗: three months

The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

IOL decentration at three years

时间窗: three years

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL decentration at two weeks

时间窗: two weeks

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

IOL decentration at one year

时间窗: one year

Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

次要结局

  • visual quality at one week(one week)
  • visual quality at two weeks(two weeks)
  • visual quality at three months(three months)
  • visual quality at six months(six months)
  • visual quality at one year(one year)
  • visual quality at one month(one month)
  • visual quality at three years(three years)

研究者

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

Jin Yang

Professor

Eye & ENT Hospital of Fudan University

研究点 (1)

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