Rotational Stability of Different Intraocular Lenses in The Capsular Bag

To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.

Study Overview

• Status: Recruiting
• Conditions: Phacoemulsification; Intraocular Lens Complication

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: AYong Yu, MD.PhD.; Phone Number: +86-0577-88068880; Email: yaybetter@hotmail.com
• Study Contact Backup: Name: Xu Shao, MD; Phone Number: 8613736995127; Email: drxushao@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Eye Hispital of Wenzhou Medical University
      • Contact: AYong Yu, MD.PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 day postoperatively
Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 week postoperatively
Alignment of intraocular lens	The alignment of intraocular lens was evaluated by anterior segment photography	1 month, postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure	Intraocular Pressure measured by non-contact tonometers	1 day, 1 week, 1 month, postoperatively
Corrected Visual Acuity (UCVA) at Distance	UCVA was determined by subjective refraction	1 day, 1 week, 1 month, postoperatively
Uncorrected Visual Acuity (UCVA) at Distance		1 day, 1 week, 1 month, postoperatively

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: AYong Yu, MD.PhD., Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Care; Rotation
• Other Study ID Numbers: 2018Rotation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No