Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

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

Study Overview

• Status: Unknown
• Conditions: Subluxation of Lens
• Intervention / Treatment: Procedure: Phacoemulsification and intraocular lens implantation for cataract

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People whose subluxation of the lens is less than 180 degrees

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Lens Diseases; Joint Dislocations; Lens Subluxation
• Other Study ID Numbers: xuwen2020-971

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