Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Sponsor

Wenzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03761745

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Complication Phacoemulsification

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Actual Study Start Date :

Dec 29, 2018

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Outcome Measures

Primary Outcome Measures

Alignment of intraocular lens [1 day postoperatively]
The alignment of intraocular lens was evaluated by anterior segment photography
Alignment of intraocular lens [1 week postoperatively]
The alignment of intraocular lens was evaluated by anterior segment photography
Alignment of intraocular lens [1 month, postoperatively]
The alignment of intraocular lens was evaluated by anterior segment photography

Secondary Outcome Measures

Intraocular Pressure [1 day, 1 week, 1 month, postoperatively]
Intraocular Pressure measured by non-contact tonometers
Corrected Visual Acuity (UCVA) at Distance [1 day, 1 week, 1 month, postoperatively]
UCVA was determined by subjective refraction
Uncorrected Visual Acuity (UCVA) at Distance [1 day, 1 week, 1 month, postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

Wenzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

A-Yong Yu, Rotational Stability of Different Intraocular Lenses in The Capsular Bag, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT03761745

Other Study ID Numbers:

2018Rotation

First Posted:

Dec 3, 2018

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by A-Yong Yu, Rotational Stability of Different Intraocular Lenses in The Capsular Bag, Wenzhou Medical University

Rotation

Postoperative Care

Study Results

No Results Posted as of Oct 6, 2021