Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04685122

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation

Condition or Disease	Intervention/Treatment	Phase
Subluxation of Lens	Procedure: Phacoemulsification and intraocular lens implantation for cataract

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Outcome Measures

Primary Outcome Measures

Lens diameter [through study completion, an average of 1 year]
Measured by related instruments before surgery and calculated by the circumference of the tension ring in the surgical video screenshot
The eccentric distance of the intraocular lens [1 week postoperation]
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The eccentric distance of the intraocular lens [1 month postoperation]
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The eccentric distance of the intraocular lens [3 month postoperation]
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The tilt angle of the intraocular lens [1 week postoperation]
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
The tilt angle of the intraocular lens [1 month postoperation]
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
The tilt angle of the intraocular lens [3 month postoperation]
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 88 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

(1) Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated

Exclusion Criteria:

(1) Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04685122

Other Study ID Numbers:

xuwen2020-971

First Posted:

Dec 28, 2020

Last Update Posted:

Dec 28, 2020

Last Verified:

Dec 1, 2020

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:

Additional relevant MeSH terms:

Joint Dislocations

Lens Subluxation

Study Results

No Results Posted as of Dec 28, 2020