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Influence of Different Toric Intraocular Lenses on IOL-capsular Complex

Primary Purpose

Corneal Astigmatism, Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cataract surgery with AcrySof IQ IOL implantation.
Cataract surgery with TECNIS toric IOL implantation.
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Astigmatism focused on measuring Various Types of toric IOLs

Eligibility Criteria

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

Inclusion Criteria:

  • The patients are diagnosed age related cataract or complicated with corneal astigmatism
  • The patients' age over 50 years old
  • The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
  • The dilated pupils are over 7mm
  • 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    AcrySof IQ toric IOL

    TECNIS toric IOL

    Arm Description

    patients who had cataract surgery with AcrySof IQ toric IOL implantation. The patients diagnosed age related cataract The patients' ages are over 50.

    patients who had cataract surgery with TECNIS toric IOL implantation. The patients are diagnosed age related cataract. The patients' ages are over 50.

    Outcomes

    Primary Outcome Measures

    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2022
    Last Updated
    April 17, 2022
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05263518
    Brief Title
    Influence of Different Toric Intraocular Lenses on IOL-capsular Complex
    Official Title
    Influence of Different Toric Intraocular Lenses on IOL-capsular Complex After Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 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
    Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. 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 because of poor post-surgery visual quality especially for optical sophisticated IOLs such as toric IOLs. IOL instability could decrease the curative effect of toric IOL. There are numerous types of toric IOLs; however, AcrySof IQ and TECNIS toric IOL are most frequently used in the Ophthalmology Hospital of Wenzhou Medical University. AcrySof IQ IOL has some differences compared with TECNIS toric IOL. IQ has a modified L haptic design while TECNIS® toric IOL has a modified C haptic design. AcrySof IQ IOL has a discontinuous 360˚ posterior square edge while TECNIS toric IOL has a continuous 360˚ posterior square edge. The AcrySof IQ IOL cylinder power models include 1.00, 1.50, 2.25, 3.00, 3.75, 4.50, 5.25 and 6.00 D. The Tecnis IOL cylinder power models include 1.00, 1.50, 2.25, 3.00 and 4.00 D. Previous study pointed that patients with cataracts with corneal astigmatism achieved comparable improvement in visual acuity, astigmatism correction, CS(sensitive contrast), rotational stability and satisfaction, following AcrySof and TECNIS toric IOL implantation. However,some other studies found that the Acrysof toric IOL showed significantly greater rotational stability than the Tecnis toric IOL and the rate of surgical IOL repositioning was higher in eyes implanted with TECNIS than with AcrySof toric IOLs for astigmatic correction. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of toric IOLs implantation in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can accurately 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
    Corneal astigmatism is refractive error that impairs uncorrected visual acuity. When patients undergo cataract surgery, implantation of toric IOL is deemed the most effective choice for correcting corneal astigmatism and reducing postoperative spectacle dependence. 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 because of poor post-surgery visual quality especially for optical sophisticated IOLs such as toric IOLs. IOL instability could decrease the curative effect of toric IOL. There are numerous types of toric IOLs; however, AcrySof IQ and TECNIS toric IOL are most frequently used in the Ophthalmology Hospital of Wenzhou Medical University. AcrySof IQ IOL has some differences compared with TECNIS toric IOL. IQ has a modified L haptic design while TECNIS® toric IOL has a modified C haptic design. AcrySof IQ IOL has a discontinuous 360˚ posterior square edge while TECNIS toric IOL has a continuous 360˚ posterior square edge. The AcrySof IQ IOL cylinder power models include 1.00, 1.50, 2.25, 3.00, 3.75, 4.50, 5.25 and 6.00 D. The Tecnis IOL cylinder power models include 1.00, 1.50, 2.25, 3.00 and 4.00 D. Previous study pointed that patients with cataracts with corneal astigmatism achieved comparable improvement in visual acuity, astigmatism correction, CS(sensitive contrast), rotational stability and satisfaction, following AcrySof and TECNIS toric IOL implantation. However,some other studies found that the Acrysof toric IOL showed significantly greater rotational stability than the Tecnis toric IOL and the rate of surgical IOL repositioning was higher in eyes implanted with TECNIS than with AcrySof toric IOLs for astigmatic correction. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of toric IOLs implantation in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can accurately 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
    Corneal Astigmatism, Cataract
    Keywords
    Various Types of toric IOLs

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    AcrySof IQ toric IOL
    Arm Type
    Experimental
    Arm Description
    patients who had cataract surgery with AcrySof IQ toric IOL implantation. The patients diagnosed age related cataract The patients' ages are over 50.
    Arm Title
    TECNIS toric IOL
    Arm Type
    Experimental
    Arm Description
    patients who had cataract surgery with TECNIS toric IOL implantation. The patients are diagnosed age related cataract. The patients' ages are over 50.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cataract surgery with AcrySof IQ IOL implantation.
    Intervention Description
    Patients in this study will receive cataract surgery with AcrySof IQ IOL implantation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cataract surgery with TECNIS toric IOL implantation.
    Intervention Description
    Patients in this study will receive cataract surgery with TECNIS toric IOL implantation.
    Primary Outcome Measure Information:
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st day after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st week after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st month after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 3rd month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 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 with corneal astigmatism The patients' age over 50 years old The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University The dilated pupils are over 7mm 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
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Influence of Different Toric Intraocular Lenses on IOL-capsular Complex

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