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NCT Number: NCT05797298

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.

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Key information

Conditions

Toric Intraocular Lens Stability Visual Quality

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye & ENT Hospital of Fudan University, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. IOL tilt at one week

    Time frame: one week

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

  12. IOL tilt at two weeks

    Time frame: two weeks

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

  13. IOL tilt at one month

    Time frame: one month

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

  14. IOL tilt at three months

    Time frame: three months

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

  15. IOL tilt at six months

    Time frame: six months

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

  16. IOL tilt at one year

    Time frame: one year

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

  17. IOL tilt at three years

    Time frame: three years

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

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

Secondary outcomes

  1. visual quality at one week

    Time frame: one week

    visual acuity was evaluated by OPD-Scan III aberrometer.

  2. visual quality at two weeks

    Time frame: two weeks

    visual acuity was evaluated by OPD-Scan III aberrometer.

  3. visual quality at one month

    Time frame: one month

    visual acuity was evaluated by OPD-Scan III aberrometer.

  4. visual quality at three months

    Time frame: three months

    visual acuity was evaluated by OPD-Scan III aberrometer.

  5. visual quality at six months

    Time frame: six months

    visual acuity was evaluated by OPD-Scan III aberrometer.

  6. visual quality at one year

    Time frame: one year

    visual acuity was evaluated by OPD-Scan III aberrometer.

  7. visual quality at three years

    Time frame: three years

    visual acuity was evaluated by OPD-Scan III aberrometer.

Other outcomes

  1. visual acuity at one day

    Time frame: one day

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one day

  2. visual acuity at three days

    Time frame: three days

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three days

  3. visual acuity at one week

    Time frame: one week

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one week

  4. visual acuity at two weeks

    Time frame: two weeks

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at two weeks

  5. visual acuity at one month

    Time frame: one month

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one month

  6. visual acuity at three months

    Time frame: three months

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three months

  7. visual acuity at six months

    Time frame: six months

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at six months

  8. visual acuity at one year

    Time frame: one year

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one year

  9. visual acuity at three years

    Time frame: three years

    uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three years

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Ma, MD

CONTACT

[email protected]

15629089882

Jin Yang, PhD

CONTACT

[email protected]

13671632525

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Apr 4, 2023
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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