The Long-term Outcome After Toric Intraocular Lens Implantation

Sponsor
Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05465447
Collaborator
(none)
60
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: subjective refraction

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Long-term Outcome After Cataract Surgery With Toric Intraocular Lens Implantation
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

    using Pentacam measure cornea astigmatism of the subjects

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

    using Pentacam measure cornea astigmatism of the subjects

  3. changes of manifest refractive astigmatism from1 -3 months after surgery to 3-5 years after surgery [1-3 months after surgery and 3-5 years after surgery]

    measured using subjective refraction by Professional optometrists

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥18years old

  • Regular astigmatism

  • Corneal astigmatism ≥ 0.75D

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05465447
Other Study ID Numbers:
  • TORIC-long term
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022