The Long-term Outcome After Toric Intraocular Lens Implantation

• Conditions: Corneal Astigmatism; Cataract
• Interventions: Device: subjective refraction

• Registration Number: NCT05465447
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study First Submitted: 2022-06-20
• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-16
• Last Update Submitted: 2022-07-16
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-08
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Toric IOL	subjective refraction	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.

Primary Outcome Measures

Name	Time	Method
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
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
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