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Status unknownNCT05465447Updated Jul 19, 2022

The Long-term Outcome After Toric Intraocular Lens Implantation

An observational study in Corneal Astigmatism and Cataract, sponsored by Wenzhou Medical University. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Wenzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 90 Years
Sex
All
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Study summary

Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, the long-term changes in the effects of toric IOLs remain unclear.

Read the detailed description

Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, there is a long-term against-the-rule (ATR) change of corneal astigmatism with aging,which influences the long-term outcomes of refractive surgery. The long-term changes in the effects of toric IOLs remain unclear. This study aim to observe the clinical effect of Toric IOL implantation in the correction of corneal astigmatism.

02

Conditions studied

  • Corneal Astigmatism
  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 60 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

From December 2012 to present, cataract patients underwent phacoemulsification combined with Toric IOL(SN6ATX) implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).

Inclusion criteria

  • ≥18years old
  • Regular astigmatism
  • Corneal astigmatism ≥ 0.75D

Exclusion criteria

Exclusion Criteria:

  • Macular degeneration and retinal disease, history of glaucoma, corneal disease
  • Previous corneal or intraocular surgery, and history of ocular inflammation.
  • Pupils can not be dilated (\< 7mm)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Toric IOL

    This study included the patients who underwent cataract surgery with the toric IOL(SN6ATX) implantation. Preoperative and postoperative corneal astigmatism, short-term and long-term postoperative total astigmatism were the main outcome indicators. Preoperative corneal astigmatism (Pentacam and IOLMaster) would be obtained from outpatient and inpatient medical records, and the IOL axis should be calculated before surgery. Short-term postoperative (1-3 months) subjective optometry results; Long-term postoperative (3-5 years) corneal astigmatism (Pentacam and IOLMaster), subjective optometry results, and axial lens would be observed using SSOCT after pupil dilation.

    Device: subjective refraction

Interventions

  • Devicesubjective refraction

    Short-term postoperative (1-3 months) and long-term postoperative (3-5 years) subjective optometry results were measured by subjective refraction.

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What researchers measure

Primary outcomes

  1. changes of magnitude of corneal astigmatism from pre-surgery to 3-5 years after surgery

    using Pentacam measure cornea astigmatism of the subjects

    Time frame: before surgery and 3-5 years after surgery

  2. changes of axis of corneal astigmatism from pre-surgery to 3-5 years after surgery

    using Pentacam measure cornea astigmatism of the subjects

    Time frame: before surgery and 3-5 years after surgery

  3. changes of manifest refractive astigmatism from1 -3 months after surgery to 3-5 years after surgery

    measured using subjective refraction by Professional optometrists

    Time frame: 1-3 months after surgery and 3-5 years after surgery

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05465447
Lead sponsor
Wenzhou Medical University
Responsible party
Yune Zhao (Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University) — Principal investigator
First posted
Jul 19, 2022
Start date
Jul 2022 (estimated)
Primary completion
Aug 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Jul 19, 2022

Study contacts

Dandan Wang, MD
Contact
604786158@qq.com
18258227706
Yune Zhao, MD
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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