CataractNCT06892470
Visual Quality of Cataract Patients with High Myopia After Implantation of Different Intraocular Lenses
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who undergo micro-incision cataract surgery and implantation of targeted intraocular lenses at the Hangzhou Branch of Wenzhou Medical University Eye Hospital.
Who may be able to join
- 1: Patients are older than 18 years
- 2: The axial length (AL) measured by IOLMaster 700 is ≥26 mm
- 3: No anterior or posterior segment pathology that could potentially compromise visual potential (such as glaucoma, myopic traction maculopathy, corneal leukoma, etc.).
- 4: Able to understand, cooperate, and complete all follow - ups
Who cannot join
- 1: History of amblyopia
- 2: Retinal detachment in the same eye or the fellow eye
- 3: Presence of multiple peripheral retinal degenerative changes
- 4: History of previous ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Postoperative Visual Outcomes in Highly Myopic Patients Implanted with Different Intraocular Lenses
This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.
- Conditions
- Cataract
- Being tested
- No intervention
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| TNF Group: | Implantation of PanOptix trifocal IOL Receives: Other: No intervention | |
| ZFR Group: | Implantation of Tecnis Symfony ZFR00 extended depth of focus IOL (Johnson \& Johnson) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defocus Curve
The defocus curve is a tool used to assess visual acuity, particularly widely applied in evaluating the performance of presbyopia-correcting intraocular lenses (IOLs). Its principle involves placing a series of positive and negative lenses of varying diopters in front of the patient's eyes to simulate different distances from near to far, thereby assessing the patient's visual acuity (VA) at each simulated distance.
Measured: Three months after operation
Visual Questionnaire
A visual questionnaire is a tool used to assess patients' visual function and quality of life. It typically includes a series of questions covering various aspects such as visual acuity at different distances (e.g., distance, intermediate, and near vision), dependency on glasses, and the impact of vision on the quality of life. By using a visual questionnaire, one can understand the actual visual experience and satisfaction of patients after the implantation of an intraocular lens.
Measured: Three months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Mar 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 62 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
- NCT06892470
- Sponsor's protocol ID
- H2025-015-K-14-04
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Visual Outcomes in Highly Myopic Patients Implanted with Different Intraocular Lenses
- ClinicalTrials.gov ID
- NCT06892470
- Acronym / sponsor ID
- H2025-015-K-14-04
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNF Group: | – | Other: No interventionImplantation of PanOptix trifocal IOL |
| ZFR Group: | – | Other: No interventionImplantation of Tecnis Symfony ZFR00 extended depth of focus IOL (Johnson \& Johnson) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who undergo micro-incision cataract surgery and implantation of targeted intraocular lenses at the Hangzhou Branch of Wenzhou Medical University Eye Hospital.
Key inclusion criteria (4 listed)
- 1: Patients are older than 18 years
- 2: The axial length (AL) measured by IOLMaster 700 is ≥26 mm
- 3: No anterior or posterior segment pathology that could potentially compromise visual potential (such as glaucoma, myopic traction maculopathy, corneal leukoma, etc.).
- 4: Able to understand, cooperate, and complete all follow - ups
Key exclusion criteria (4 listed)
- 1: History of amblyopia
- 2: Retinal detachment in the same eye or the fellow eye
- 3: Presence of multiple peripheral retinal degenerative changes
- 4: History of previous ocular surgery
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 |
|---|---|---|
| No interventionNo intervention | Other | TNF Group:, ZFR Group: |
Primary outcome
Defocus Curve
Time frame: Three months after operation
The defocus curve is a tool used to assess visual acuity, particularly widely applied in evaluating the performance of presbyopia-correcting intraocular lenses (IOLs). Its principle involves placing a series of positive and negative lenses of varying diopters in front of the patient's eyes to simulate different distances from near to far, thereby assessing the patient's visual acuity (VA) at each simulated distance.
Visual Questionnaire
Time frame: Three months after operation
A visual questionnaire is a tool used to assess patients' visual function and quality of life. It typically includes a series of questions covering various aspects such as visual acuity at different distances (e.g., distance, intermediate, and near vision), dependency on glasses, and the impact of vision on the quality of life. By using a visual questionnaire, one can understand the actual visual experience and satisfaction of patients after the implantation of an intraocular lens.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defocus Curve (time frame: Three months after operation). The study lists 2 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 24 Mar 2025.