The Long-term Outcome After Toric Intraocular Lens Implantation

NCT ID: NCT05465447

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-10-31

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.

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.

Conditions

Corneal Astigmatism; Cataract

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

subjective refraction

Intervention Type: DEVICE

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

Interventions

subjective refraction

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dandan Wang, MD

Role: CONTACT

604786158@qq.com

18258227706

Yune Zhao, MD

Role: CONTACT

Other Identifiers

TORIC-long term

Identifier Type: -

Identifier Source: org_study_id