Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability
1 other identifier
observational
60
1 country
1
Brief Summary
To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedDecember 28, 2020
December 1, 2020
8 months
December 16, 2020
December 22, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
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
Interventions
Phacoemulsification and intraocular lens implantation for cataract
Eligibility Criteria
People whose subluxation of the lens is less than 180 degrees
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2020
First Posted
December 28, 2020
Study Start
November 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
December 28, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share