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
About this trial
This is an interventional treatment trial for Corneal Astigmatism focused on measuring Various Types of toric IOLs
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
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
NCT ID
NCT05263518
First Posted
February 21, 2022
Last Updated
April 17, 2022
Sponsor
Wenzhou Medical University
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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