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Completed

NCT Number: NCT05530473

Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.

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Key information

Conditions

Intraocular Lens Rotation Capsular Tension Ring

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-cataract

Exclusion criteria

  • preexisting corneal pathology
  • small pupil
  • glaucoma
  • zonular dehiscence
  • a history of ocular trauma or surgery
  • uveitis
  • intraoperative complications

Treatment and study plan

capsular tension ring

Device

To insert a capsular tension ring during the cataract surgery

Other names: capsular tension ring (ACPi-11; Bausch&Lomb)

Primary outcomes

  1. IOL rotation degree at one hour

    Time frame: one hour

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  2. IOL rotation degree at 1 day

    Time frame: one day

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  3. IOL rotation degree at 3 days

    Time frame: three days

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  4. IOL rotation degree at 1 week

    Time frame: one week

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  5. IOL rotation degree at 2 weeks

    Time frame: two weeks

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  6. IOL rotation degree at 1 month

    Time frame: one month

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  7. IOL rotation degree at 3 months

    Time frame: three months

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  8. IOL rotation degree at 6 months

    Time frame: three months

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  9. IOL rotation degree at 12 months

    Time frame: three months

    After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

  10. Residual astigmatism (RAS) at two weeks

    Time frame: two weeks

    RAS after surgery, which was measured as manifest refraction at two weeks

  11. Residual astigmatism (RAS) at one month

    Time frame: one month

    RAS after surgery, which was measured as manifest refraction at one month

Secondary outcomes

  1. visual acuity (VA) at 1 day

    Time frame: two weeks

    Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks

  2. visual acuity (VA) at 3 days

    Time frame: two weeks

    Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks

  3. visual acuity (VA) at 1 weeks

    Time frame: two weeks

    Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks

  4. visual acuity (VA) at 2 weeks

    Time frame: two weeks

    Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks

  5. visual acuity (VA) at 1 month

    Time frame: one month

    Uncorrected distance visual acuity (UDVA) of participants after surgery at one month

  6. visual acuity (VA) at 3 months

    Time frame: three months

    Uncorrected distance visual acuity (UDVA) of participants after surgery at three months

  7. visual acuity (VA) at 6 months

    Time frame: six months

    Uncorrected distance visual acuity (UDVA) of participants after surgery at six months

  8. visual acuity (VA) at 12 months

    Time frame: twelve months

    Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months

  9. IOL tilt at 1 day

    Time frame: one day

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

  10. IOL tilt at 3 days

    Time frame: three days

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

  11. IOL tilt at 1 week

    Time frame: one week

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

  12. IOL tilt at 2 weeks

    Time frame: two weeks

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

  13. IOL tilt at 1 month

    Time frame: one month

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

  14. IOL tilt at 3 months

    Time frame: three months

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

  15. IOL tilt at 6 months

    Time frame: six months

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

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Apr 28, 2023

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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