Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Phacoemulsification Clinical Trial

Official title:

Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03761745
• Other study ID #: 2018Rotation
• Status: Recruiting
• Start date: December 29, 2018
• Est. completion date: October 30, 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 evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
• The operation was smooth and there were no surgical complications.

Exclusion Criteria:

• Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
• History of ocular trauma or surgery before this cataract surgery;
• intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
• Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;

Related Conditions & MeSH terms

• Intraocular Lens Complication
• Phacoemulsification

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	Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 day postoperatively
Primary	Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 week postoperatively
Primary	Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 month, postoperatively
Secondary	Intraocular Pressure	Intraocular Pressure measured by non-contact tonometers	1 day, 1 week, 1 month, postoperatively
Secondary	Corrected Visual Acuity (UCVA) at Distance	UCVA was determined by subjective refraction	1 day, 1 week, 1 month, postoperatively
Secondary	Uncorrected Visual Acuity (UCVA) at Distance		1 day, 1 week, 1 month, postoperatively