Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT

Age-related Cataract Clinical Trial

Official title:

Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148741
• Other study ID #: SS-OCT plate-haptic
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.

Description:

Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

-patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Exclusion Criteria:

• people cannot cooperate with the check, corneal opacity, glaucoma, and other eye diseases
• any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
• Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsular bend index (CBI)	capsule bend formation has 5 continuous stages from 0 to 4,The stage score varies over different positions of the same capsule bag, because the capsule bend formation is inconsistent along the entire optic edge. CBI is the mean of the different stage scores in different positions and represents the general capsule bend state of the whole capsule bag.	2020.12.1