Accuracy of Corneal Astigmatism in Different Region Modes

Astigmatism Clinical Trial

Official title:

Accuracy of Corneal Astigmatism in Different Region Modes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299530
• Other study ID #: 2017ASTIGMATISM REGIONS
• Status: Recruiting
• Start date: October 10, 2017
• Est. completion date: October 28, 2024

Study information

• Verified date: December 2023
• Source: Wenzhou Medical University
• Contact: AYong Yu, MD.PhD.
• Phone: +86-0577-88068880
• Email: yaybetter[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To analyze the difference between measured total corneal astigmatism and actual corneal astigmatism under different region modes and optimize the region setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 28, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.
• Best corrected visual acuity = 0.66 (20/30 Snellen)

Exclusion Criteria:

• Corneal diseases or severe irregular astigmatism (e.g., pterygium, keratoconus), existence of corneal opacification;
• Ocular disease which may affect visual acuity (e.g., glaucoma, uveitis, retinal disease, pathologic myopia);
• History of ocular surgery or ocular trauma before this cataract surgery;
• Decentration of IOL > 0.3mm or tilt > 5°
• Implantation of multifocal IOL
• history of wearing of rigid contact lens within the past 4 weeks or soft contact lens within 1 week;

Related Conditions & MeSH terms

• Astigmatism
• Cornea

Intervention

Other:
• patients with corneal astigmatism
The total corneal astigmatism, anterior chamber depth, will be measured by a Scheimpflug tomographer. Pupil size will be measured by itrace device and MONCV3 device. Residual astigmatism will be tested by subjective refraction.

Locations

Country	Name	City	State
China	Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vectorial difference	The vectorial difference between measured corneal astigmatism (under multiple different region mode settings) and actual corneal astigmatism.	=1 month after surgery
Primary	pupil size	pupil size of patients in a bright environment measured by itrace device and MONCV3 device	=1 month after surgery
Primary	pupil size 2	pupil size of patients measured by Pentacam HR device	=1 month after surgery
Primary	residual astigmatism	residual astigmatism tested by subjective refraction	=1 month after surgery
Primary	total corneal astigmatism	Total corneal astigmatism measured by a scheimpflug tomographer under different region mode settings.	=1 month after surgery
Primary	Anterior chamber depth	The distance between corneal apex and anterior surface of IOL measured by a scheimpflug tomographer	=1 month after surgery
Primary	actual corneal astigmatism	actual corneal astigmatism is derived from residual astigmatism at corneal plane and cylindrical power of IOL at corneal plane through Holladay 2 formula.	=1 month after surgery