The Long-term Outcome After Toric Intraocular Lens Implantation

Cataract Clinical Trial

Official title:

The Long-term Outcome After Cataract Surgery With Toric Intraocular Lens Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465447
• Other study ID #: TORIC-long term
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: Wenzhou Medical University
• Contact: Dandan Wang, MD
• Phone: 18258227706
• Email: 604786158[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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