Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
1 other identifier
observational
3,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
June 19, 2025
June 1, 2025
10.8 years
November 23, 2022
June 16, 2025
Conditions
Outcome Measures
Primary Outcomes (24)
IOL rotation degree at 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.
one hour
IOL rotation degree at 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.
one day
IOL rotation degree at 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.
three days
IOL rotation degree at 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.
one week
IOL rotation degree at 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.
two weeks
IOL rotation degree at 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.
one month
IOL rotation degree at 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.
three months
IOL rotation degree at 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.
six months
IOL rotation degree at 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.
one year
IOL rotation degree at 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.
three years
IOL tilt at one week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
one week
IOL tilt at two weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
two weeks
IOL tilt at one month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
one month
IOL tilt at three months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
three months
IOL tilt at six months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
six months
IOL tilt at one year
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
one year
IOL tilt at three years
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
three years
IOL decentration at 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.
one week
IOL decentration at 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.
two weeks
IOL decentration at 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.
one month
IOL decentration at 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.
three months
IOL decentration at 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.
six months
IOL decentration at 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.
one year
IOL decentration at 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.
three years
Secondary Outcomes (7)
visual quality at one week
one week
visual quality at two weeks
two weeks
visual quality at one month
one month
visual quality at three months
three months
visual quality at six months
six months
- +2 more secondary outcomes
Other Outcomes (9)
visual acuity at one day
one day
visual acuity at three days
three days
visual acuity at one week
one week
- +6 more other outcomes
Study Arms (1)
cataract patients implanted with toric IOLs
Cataract patients who received the implantation of different toric IOLs with different haptic designs
Eligibility Criteria
Cataract patients who underwent uneventful lens phacoemulsification and toric IOL implantation.
You may qualify if:
- Cataract
You may not qualify if:
- small pupil
- zonular dehiscence
- preexisting corneal pathology
- glaucoma
- uveitis
- a history of ocular trauma or surgery
- severe intraoperative and postoperative complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eye & ENT Hospital of Fudan University
Shanghai, China, 200031, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Yang, PhD
Eye & ENT Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 23, 2022
First Posted
April 4, 2023
Study Start
June 1, 2019
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
May 31, 2030
Last Updated
June 19, 2025
Record last verified: 2025-06