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

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

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

Study Overview

• Status: Completed
• Conditions: Age-related Cataract

Detailed 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.

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

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients were divided into 2 groups according to the different intraocular lenses implanted: 39 eyes were implanted with the C-loop haptic intraocular lens (Acrysof) while the other 41 eyes were implanted with plate haptic intraocular lenses (CT ASPHINA 509 M).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; implanted with the C-loop haptic intraocular lens
Group 2; implanted with the plate haptic intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: SS-OCT; capsule bag
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SS-OCT plate-haptic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No