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Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT

Primary Purpose

High Myopia, Capsular Tension Ring

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cataract surgery with IOL implantation and with/without capsular tension ring implatation
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Myopia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients are diagnosed age related cataract with axial length over 26mm
  • The patients' age over 50 years old
  • The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
  • The dialated pupils are over 6mm
  • Patients are willing and able to complete the follow-ups.

Exclusion Criteria:

  • Patients with other type of cataract
  • Patients have complications in the surgery and after surgery
  • Patients have other severe diseases of eyes

Sites / Locations

  • Eye Hospital of Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High myopia patients who had cataract surgery with IOL and capsular tension ring implantation

High myopia patients who had cataract surgery with IOL implantation

Arm Description

The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50

The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50

Outcomes

Primary Outcome Measures

The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
The position of IOL
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2021
Last Updated
October 13, 2021
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05095194
Brief Title
Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
Official Title
Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.
Detailed Description
The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation.Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Capsular tension rings were first introduced in the early 1990s for loosening and tightening the lens bag and maintaining the equatorial contour of the bag after cataract surgery.Today, capsular tension rings of many different designs are in use.The capsular tension rings can be used in eyes with fragile and split zonular fibers, as well as pseudoexfoliation, high myopia, Marfan syndrome, mature cataract and lens subluxation.The capsular tension ring reduces the incidence of decentration and tilt of the IOL by reducing capsular contraction. In addition, multi-focus IOL implantation combine with capsular tension ring result in smaller high-order aberrations in our eyes compared to cataract surgery with multi-focus IOL implantation alone.For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt ,decentration and displacement of IOL.Currently, there is no literature guidance to compare the results of cataract surgery combined with or without capsular tension ring implantation in patients with high myopia.Our hospital has Swept-source Optical Coherence Tomography ( SS-OCT,Casia2, TOMEY, Japan), which can accurately photograph the process of IOL capsule bending and the changes of lens position after cataract surgery. SS-OCT can be used to evaluate the influence of capsular tension ring on the dynamic changes of IOL-capsular complex in patients with high myopia after cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Capsular Tension Ring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High myopia patients who had cataract surgery with IOL and capsular tension ring implantation
Arm Type
Experimental
Arm Description
The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50
Arm Title
High myopia patients who had cataract surgery with IOL implantation
Arm Type
Experimental
Arm Description
The patients' axial length is over 26 mm and are diagnosed age related cataract The patients' age are over 50
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery with IOL implantation and with/without capsular tension ring implatation
Intervention Description
Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation
Primary Outcome Measure Information:
Title
The position of IOL
Description
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Time Frame
The 1st day after surgery
Title
The position of IOL
Description
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Time Frame
The 1st week after surgery
Title
The position of IOL
Description
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Time Frame
The 1st month after surgery
Title
The position of IOL
Description
Evaluation of the position of IOL through tilt,decentration and the process of capsule bending.
Time Frame
The 3rd month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients are diagnosed age related cataract with axial length over 26mm The patients' age over 50 years old The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University The dialated pupils are over 6mm Patients are willing and able to complete the follow-ups. Exclusion Criteria: Patients with other type of cataract Patients have complications in the surgery and after surgery Patients have other severe diseases of eyes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pingjun Chang
Phone
18868410303
Email
364669877@qq.com
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pingjun Chang
Phone
18868410303
Email
364669877@qq.com
First Name & Middle Initial & Last Name & Degree
Eye Hospital of Wenzhou Medical College Chang
Phone
18868410303
Email
364669877@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Influence of Capsular Tension Ring on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT

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