Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Subluxation of Lens Clinical Trial

Official title:

Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04685122
• Other study ID #: xuwen2020-971
• Status: Active, not recruiting
• Start date: November 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Lens Subluxation
• Subluxation of Lens

Intervention

Procedure:
• Phacoemulsification and intraocular lens implantation for cataract
Phacoemulsification and intraocular lens implantation for cataract

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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