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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

NCT ID: NCT05095194

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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High Myopia Capsular Tension Ring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

Cataract surgery with IOL implantation and with/without capsular tension ring implatation

Intervention Type PROCEDURE

Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation

High myopia patients who had cataract surgery with IOL implantation

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

Group Type EXPERIMENTAL

Cataract surgery with IOL implantation and with/without capsular tension ring implatation

Intervention Type PROCEDURE

Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation

Interventions

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Cataract surgery with IOL implantation and with/without capsular tension ring implatation

Patients in this study will receive cataract surgery with IOL implantation and capsular tension ring implantation or cataract surgery with IOL implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital of Wenzhou Medical College

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Pingjun Chang

Role: CONTACT

Phone: 18868410303

Email: [email protected]

Facility Contacts

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Pingjun Chang

Role: primary

Eye Hospital of Wenzhou Medical College Chang

Role: backup

Other Identifiers

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20210929CTR

Identifier Type: -

Identifier Source: org_study_id