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

NCT05095194 | Unknown

• 1 other identifier: 20210929CTR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia; Capsular Tension Ring

Outcome Measures

Primary Outcomes (4)

• The position of IOL

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

  The 1st day after surgery

• The position of IOL

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

  The 1st week after surgery

• The position of IOL

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

  The 1st month after surgery

• The position of IOL

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

  The 3rd month after surgery

Study Arms (2)

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

EXPERIMENTAL

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

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

High myopia patients who had cataract surgery with IOL implantation

EXPERIMENTAL

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

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

Interventions

Cataract surgery with IOL implantation and with/without capsular tension ring implatation 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 and capsular tension ring implantation; High myopia patients who had cataract surgery with IOL implantation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Pingjun Chang

CONTACT

18868410303; 364669877@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 27, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

CN (1)