Corneal AstigmatismNCT05465447
The Long-term Outcome After Toric Intraocular Lens Implantation
An observational study of 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 18 to 90 years
- Conditions the study is for
- Corneal Astigmatism, Cataract
- What is being tested?
- subjective refraction
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Oct 2022
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From December 2012 to present, cataract patients underwent phacoemulsification combined with Toric IOL(SN6ATX) implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).
Who may be able to join
- ≥18years old
- Regular astigmatism
- Corneal astigmatism ≥ 0.75D
Who cannot join
- Macular degeneration and retinal disease, history of glaucoma, corneal disease
- Previous corneal or intraocular surgery, and history of ocular inflammation.
- Pupils can not be dilated (< 7mm)
Trial locations and contacts
No sites are listed yet.
Yune Zhao, MD contact
About this study
Official title: The Long-term Outcome After Cataract Surgery With Toric Intraocular Lens Implantation
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. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, the long-term changes in the effects of toric IOLs remain unclear.
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. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, there is a long-term against-the-rule (ATR) change of corneal astigmatism with aging，which influences the long-term outcomes of refractive surgery. The long-term changes in the effects of toric IOLs remain unclear. This study aim to observe the clinical effect of Toric IOL implantation in the correction of corneal astigmatism.
- Conditions
- Corneal Astigmatism, Cataract
- Being tested
- subjective refraction
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjective refractionDevice
Short-term postoperative (1-3 months) and long-term postoperative (3-5 years) subjective optometry results were measured by subjective refraction.
| Study group | Role | What they receive |
|---|---|---|
| Toric IOL | This study included the patients who underwent cataract surgery with the toric IOL(SN6ATX) implantation. Preoperative and postoperative corneal astigmatism, short-term and long-term postoperative total astigmatism were the main outcome indicators. Preoperative corneal astigmatism (Pentacam and IOLMaster) would be obtained from outpatient and inpatient medical records, and the IOL axis should be calculated before surgery. Short-term postoperative (1-3 months) subjective optometry results; Long-term postoperative (3-5 years) corneal astigmatism (Pentacam and IOLMaster), subjective optometry results, and axial lens would be observed using SSOCT after pupil dilation. Receives: Device: subjective refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of magnitude of corneal astigmatism from pre-surgery to 3-5 years after surgery
using Pentacam measure cornea astigmatism of the subjects
Measured: before surgery and 3-5 years after surgery
changes of axis of corneal astigmatism from pre-surgery to 3-5 years after surgery
using Pentacam measure cornea astigmatism of the subjects
Measured: before surgery and 3-5 years after surgery
changes of manifest refractive astigmatism from1 -3 months after surgery to 3-5 years after surgery
measured using subjective refraction by Professional optometrists
Measured: 1-3 months after surgery and 3-5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465447
- Sponsor's protocol ID
- TORIC-long term
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Outcome After Cataract Surgery With Toric Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT05465447
- Acronym / sponsor ID
- TORIC-long term
- Conditions
- Corneal Astigmatism, Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Jul 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. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, the long-term changes in the effects of toric IOLs remain unclear.
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. Previous studies report that the visual effects and rotational stability of toric IOLs are well maintained over 1- or 2-year follow-up periods. However, there is a long-term against-the-rule (ATR) change of corneal astigmatism with aging，which influences the long-term outcomes of refractive surgery. The long-term changes in the effects of toric IOLs remain unclear. This study aim to observe the clinical effect of Toric IOL implantation in the correction of corneal astigmatism.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toric IOL | – | Device: subjective refractionThis study included the patients who underwent cataract surgery with the toric IOL(SN6ATX) implantation. Preoperative and postoperative corneal astigmatism, short-term and long-term postoperative total astigmatism were the main outcome indicators. Preoperative corneal astigmatism (Pentacam and IOLMaster) would be obtained from outpatient and inpatient medical records, and the IOL axis should be calculated before surgery. Short-term postoperative (1-3 months) subjective optometry results; Long-term postoperative (3-5 years) corneal astigmatism (Pentacam and IOLMaster), subjective optometry results, and axial lens would be observed using SSOCT after pupil dilation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From December 2012 to present, cataract patients underwent phacoemulsification combined with Toric IOL(SN6ATX) implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).
Key inclusion criteria (3 listed)
- ≥18years old
- Regular astigmatism
- Corneal astigmatism ≥ 0.75D
Key exclusion criteria (3 listed)
- Macular degeneration and retinal disease, history of glaucoma, corneal disease
- Previous corneal or intraocular surgery, and history of ocular inflammation.
- Pupils can not be dilated (< 7mm)
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 |
|---|---|---|
| subjective refractionShort-term postoperative (1-3 months) and long-term postoperative (3-5 years) subjective optometry results were measured by subjective refraction. | Device | Toric IOL |
Primary outcome
changes of magnitude of corneal astigmatism from pre-surgery to 3-5 years after surgery
Time frame: before surgery and 3-5 years after surgery
using Pentacam measure cornea astigmatism of the subjects
changes of axis of corneal astigmatism from pre-surgery to 3-5 years after surgery
Time frame: before surgery and 3-5 years after surgery
using Pentacam measure cornea astigmatism of the subjects
changes of manifest refractive astigmatism from1 -3 months after surgery to 3-5 years after surgery
Time frame: 1-3 months after surgery and 3-5 years after surgery
measured using subjective refraction by Professional optometrists
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 Jul 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 Dandan Wang, MD (18258227706, 604786158@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of magnitude of corneal astigmatism from pre-surgery to 3-5 years after surgery (time frame: before surgery and 3-5 years after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.