Corneal AstigmatismNCT05263518
Influence of Different Toric Intraocular Lenses on IOL-capsular Complex
A study testing Cataract surgery with AcrySof IQ IOL implantation. and Cataract surgery with TECNIS toric IOL implantation. in people with Corneal Astigmatism and Cataract, run by Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Corneal Astigmatism, Cataract
- What is being tested?
- Cataract surgery with AcrySof IQ IOL implantation. and Cataract surgery with TECNIS toric IOL implantation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with other type of cataract
- Patients have complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Trial locations and contacts
No sites are listed yet.
Yune Zhao, MD contact
About this study
Official title: Influence of Different Toric Intraocular Lenses on IOL-capsular Complex After Cataract Surgery
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.
Read the 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.
- Conditions
- Corneal Astigmatism, Cataract
- Being tested
- Cataract surgery with AcrySof IQ IOL implantation., Cataract surgery with TECNIS toric IOL implantation.
- Keywords
- Various Types of toric IOLs
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with AcrySof IQ IOL implantation.Procedure or surgery
Patients in this study will receive cataract surgery with AcrySof IQ IOL implantation.
Cataract surgery with TECNIS toric IOL implantation.Procedure or surgery
Patients in this study will receive cataract surgery with TECNIS toric IOL implantation.
| Study group | Role | What they receive |
|---|---|---|
| AcrySof IQ toric IOL | Experimental | patients who had cataract surgery with AcrySof IQ toric IOL implantation. The patients diagnosed age related cataract The patients' ages are over 50. Receives: Procedure: Cataract surgery with AcrySof IQ IOL implantation. |
| TECNIS toric IOL | Experimental | patients who had cataract surgery with TECNIS toric IOL implantation. The patients are diagnosed age related cataract. The patients' ages are over 50. Receives: Procedure: Cataract surgery with TECNIS toric IOL implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）
Measured: The 1st day after surgery
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）
Measured: The 1st week after surgery
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）
Measured: The 1st month after surgery
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）
Measured: The 3rd month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263518
- Sponsor's protocol ID
- TORIC stability
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Lou X, Qian S, Li Y, Wu X, Li S, Wang Y, Zhao Y, Chang P. Comparison of the effect of capsular bend on the rotational stability between 2 toric intraocular lenses. J Cataract Refract Surg. 2024 Mar 1;50(3):283-288. doi: 10.1097/j.jcrs.0000000000001373.
PubMed 38085243
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Toric Intraocular Lenses on IOL-capsular Complex After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05263518
- Acronym / sponsor ID
- TORIC stability
- Conditions
- Corneal Astigmatism, Cataract
- Keywords
- Various Types of toric IOLs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcrySof IQ toric IOL | Experimental | Procedure: Cataract surgery with AcrySof IQ IOL implantation.patients who had cataract surgery with AcrySof IQ toric IOL implantation. The patients diagnosed age related cataract The patients' ages are over 50. |
| TECNIS toric IOL | Experimental | Procedure: Cataract surgery with TECNIS toric IOL implantation.patients who had cataract surgery with TECNIS toric IOL implantation. The patients are diagnosed age related cataract. The patients' ages are over 50. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with other type of cataract
- Patients have complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgery with AcrySof IQ IOL implantation.Patients in this study will receive cataract surgery with AcrySof IQ IOL implantation. | Procedure or surgery | AcrySof IQ toric IOL |
| Cataract surgery with TECNIS toric IOL implantation.Patients in this study will receive cataract surgery with TECNIS toric IOL implantation. | Procedure or surgery | TECNIS toric IOL |
Primary outcome
The position of IOL
Time frame: The 1st day after surgery
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
Time frame: The 1st week after surgery
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
Time frame: The 1st month after surgery
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
Time frame: The 3rd month after surgery
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）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 38085243Wang Y, Lou X, Qian S, Li Y, Wu X, Li S, Wang Y, Zhao Y, Chang P. Comparison of the effect of capsular bend on the rotational stability between 2 toric intraocular lenses. J Cataract Refract Surg. 2024 Mar 1;50(3):283-288. doi: 10.1097/j.jcrs.0000000000001373.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yune Zhao, MD contact
Yune Zhao study director
Ophthalmology and Optometry Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery with AcrySof IQ IOL implantation. and Cataract surgery with TECNIS toric IOL implantation. in people with Corneal Astigmatism and Cataract, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pingjun Chang (18868410303, 364669877@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of IOL (time frame: The 1st day after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.