Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

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

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.

Study Overview

• Status: Recruiting
• Conditions: Visual Quality; Toric Intraocular Lens Stability

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Jin Yang, PhD; Phone Number: 13671632525; Email: jin_er76@hotmail.com
• Study Contact Backup: Name: Dongmei Ma, MD; Phone Number: 15629089882; Email: docmdm@163.com

Study Locations

• China
  • Shanghai, China, 200031
    • Recruiting
    • Eye & ENT Hospital of Fudan University
    • Contact: Jin Yang, PhD; Phone Number: 13671632525; Email: jin_er76@hotmail.com
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye & ENT Hospital of Fudan University
      • Contact: Jin Yang, PhD; Phone Number: 13671632525; Email: jin_er76@hotmail.com
      • Principal Investigator: Lei Cai, MD
      • Principal Investigator: Dongmei Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cataract patients who underwent uneventful lens phacoemulsification and toric IOL implantation.

Description

Inclusion Criteria:

• Cataract

Exclusion Criteria:

• • small pupil

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cataract patients implanted with toric IOLs; Cataract patients who received the implantation of different toric IOLs with different haptic designs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual quality at one week	visual acuity was evaluated by OPD-Scan III aberrometer.	one week
visual quality at two weeks	visual acuity was evaluated by OPD-Scan III aberrometer.	two weeks
visual quality at one month	visual acuity was evaluated by OPD-Scan III aberrometer.	one month
visual quality at three months	visual acuity was evaluated by OPD-Scan III aberrometer.	three months
visual quality at six months	visual acuity was evaluated by OPD-Scan III aberrometer.	six months
visual quality at one year	visual acuity was evaluated by OPD-Scan III aberrometer.	one year
visual quality at three years	visual acuity was evaluated by OPD-Scan III aberrometer.	three years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity at one day	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one day	one day
visual acuity at three days	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three days	three days
visual acuity at one week	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one week	one week
visual acuity at two weeks	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at two weeks	two weeks
visual acuity at one month	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one month	one month
visual acuity at three months	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three months	three months
visual acuity at six months	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at six months	six months
visual acuity at one year	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one year	one year
visual acuity at three years	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three years	three years

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Jin Yang, PhD, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: April 1, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Toric IOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No