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Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05797298
Enrollment
3000
Registered
2023-04-04
Start date
2019-06-01
Completion date
2030-05-31
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toric Intraocular Lens Stability, Visual Quality

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.

Interventions

None listed

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IOL decentration at three yearsthree yearsDecentration 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 six monthssix monthsAfter 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 yearone yearAfter 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 yearsthree yearsAfter 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 one weekone weekThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at two weekstwo weeksThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one monthone monthThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three monthsthree monthsThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at six monthssix monthsThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one yearone yearThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three yearsthree yearsThe tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at one weekone weekDecentration 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 weekstwo weeksDecentration 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 monthone monthDecentration 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 three monthsthree monthsDecentration 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 six monthssix monthsDecentration 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 yearone yearDecentration 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 weekone weekAfter 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 hourone hourAfter 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 dayone dayAfter 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 daysthree daysAfter 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 weekstwo weeksAfter 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 monthone monthAfter 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 monthsthree monthsAfter 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.

Secondary

MeasureTime frameDescription
visual quality at two weekstwo weeksvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at one monthone monthvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at three monthsthree monthsvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at six monthssix monthsvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at one yearone yearvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at three yearsthree yearsvisual acuity was evaluated by OPD-Scan III aberrometer.
visual quality at one weekone weekvisual acuity was evaluated by OPD-Scan III aberrometer.

Other

MeasureTime frameDescription
visual acuity at three yearsthree yearsuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three years
visual acuity at three daysthree daysuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three days
visual acuity at one dayone dayuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one day
visual acuity at one weekone weekuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one week
visual acuity at two weekstwo weeksuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at two weeks
visual acuity at one monthone monthuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one month
visual acuity at three monthsthree monthsuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three months
visual acuity at six monthssix monthsuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at six months
visual acuity at one yearone yearuncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one year

Countries

China

Contacts

Primary ContactDongmei Ma, MD
docmdm@163.com15629089882
Backup ContactJin Yang, PhD
jin_er76@hotmail.com13671632525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026