Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- IOL tilt at six months
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •• small pupil
- •zonular dehiscence
- •preexisting corneal pathology
- •a history of ocular trauma or surgery
- •severe intraoperative and postoperative complications
Outcomes
Primary Outcomes
IOL tilt at six months
Time Frame: six months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one week
Time Frame: one week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one year
Time Frame: one year
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one month
Time Frame: one month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL rotation degree at three months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: two weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three years
Time Frame: three years
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at six months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: three months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at three years
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Jin Yang
Professor
Eye & ENT Hospital of Fudan University