NCT05797298

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jun 2019May 2030

Study Start

First participant enrolled

June 1, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

10.8 years

First QC Date

November 23, 2022

Last Update Submit

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

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Study Officials

  • Jin Yang, PhD

    Eye & ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ma, MD

CONTACT

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

Locations