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

NCT05148741 | Completed

• 1 other identifier: SS-OCT plate-haptic
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Age-related Cataract

Keywords

SS-OCT; capsule bag

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

implanted with the C-loop haptic intraocular lens

Group 2

implanted with the plate haptic intraocular lens

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

Study Officials

• Yune Zhao

  Ophthalmology and Optometry Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: December 8, 2021
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CN (1)