The Long-term Outcome After Toric Intraocular Lens Implantation

NCT05465447 | Unknown

• 1 other identifier: TORIC-long term
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Corneal Astigmatism; Cataract

Outcome Measures

Primary Outcomes (3)

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

  using Pentacam measure cornea astigmatism of the subjects

  before surgery and 3-5 years after surgery

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

  using Pentacam measure cornea astigmatism of the subjects

  before surgery and 3-5 years after surgery

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

  measured using subjective refraction by Professional optometrists

  1-3 months after surgery and 3-5 years after surgery

Study Arms (1)

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

subjective refraction DEVICE

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

Toric IOL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wenzhou Medical University: lead

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Central Study Contacts

Dandan Wang, MD

CONTACT

18258227706; 604786158@qq.com

Yune Zhao, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 19, 2022
• Study Start: July 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07