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IOL-capsular Complex After Different Intraocular Lenses Implantation in Patients With High Myopia

Primary Purpose

Age-related Cataract

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
one-piece
plate-haptic
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cataract focused on measuring High Myopia, Various Types of IOLs, The position of IOL

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients are diagnosed age related cataract or complicated cataract with axial length over 26mm
  • The patients' age over 18 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 types 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 CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

one-piece

plate-haptic

Arm Description

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

Outcomes

Primary Outcome Measures

The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2021
Last Updated
February 21, 2022
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05255796
Brief Title
IOL-capsular Complex After Different Intraocular Lenses Implantation in Patients With High Myopia
Official Title
Influence of Different Intraocular Lenses 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
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
August 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. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. 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 various types of IOLs implantation in patients with high myopia. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after 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. Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed for any design of IOL, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. However, there is scarce evidence on characteristics and factors associated with clinically significant IOL decentration and tilt in highly myopic eyes. 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 various types of IOLs implantation in patients with high myopia. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract
Keywords
High Myopia, Various Types of IOLs, The position of IOL

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
one-piece
Arm Type
Experimental
Arm Description
The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.
Arm Title
plate-haptic
Arm Type
Experimental
Arm Description
The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.
Intervention Type
Procedure
Intervention Name(s)
one-piece
Intervention Description
Patients underwent phacoemulsification cataract surgery with one-piece IOL implantation.
Intervention Type
Procedure
Intervention Name(s)
plate-haptic
Intervention Description
Patients underwent phacoemulsification cataract surgery with plate-haptic 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 using CASIA2.
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 using CASIA2.
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 using CASIA2.
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 using CASIA2.
Time Frame
The 3rd month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients are diagnosed age related cataract or complicated cataract with axial length over 26mm The patients' age over 18 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 types 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
First Name & Middle Initial & Last Name or Official Title & Degree
Yune Zhao, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yune Zhao
Organizational Affiliation
Ophthalmology and Optometry Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pingjun Chang
Phone
18868410303
Email
364669877@qq.com

12. IPD Sharing Statement

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IOL-capsular Complex After Different Intraocular Lenses Implantation in Patients With High Myopia

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