Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

Recruiting

• Conditions: Toric Intraocular Lens Stability; Visual Quality

• Registration Number: NCT05797298
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2022-11-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-01
• Last Update Submitted: 2023-04-01
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOL tilt at six months	six months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one year	one year	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL rotation degree at three months	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.
IOL rotation degree at one hour	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.
IOL rotation degree at one week	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.
IOL tilt at two weeks	two weeks	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at three years	three years	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at six months	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.
IOL rotation degree at one day	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.
IOL rotation degree at three days	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.
IOL rotation degree at one year	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.
IOL decentration at three months	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.
IOL rotation degree at two weeks	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.
IOL rotation degree at one month	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.
IOL rotation degree at six months	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.
IOL rotation degree at three years	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.
IOL tilt at one week	one week	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at one month	one month	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at one week	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.
IOL decentration at one month	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.
IOL tilt at three months	three months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL decentration at three years	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.
IOL decentration at two weeks	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.
IOL decentration at one year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China