the Accuracy of Intraocular Lens Calculation FormulaNCT05672693
Study on the Accuracy of Intraocular Lens Calculation Formula
An observational study of the Accuracy of Intraocular Lens Calculation Formula, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- the Accuracy of Intraocular Lens Calculation Formula
- What is being tested?
- Several Calculation Formulas of Intraocular Lens
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were previously diagnosed as "senile cataract" in the Ophthalmology Center of the Second Affiliated Hospital of Zhejiang University Medical College and who performed "phacoemulsification cataract extraction combined with intraocular lens implantation"
Who may be able to join
- (1) Conform to the diagnosis of cataract; (2) No complications occurred during and after operation; (3) Before and after operation, the measurement of ocular biological characteristics and refractive state can be successfully completed; (4) Patients who can be followed up regularly after operation.
Who cannot join
- (1) Serious intraoperative or postoperative complications; (2) Complicated with other eye diseases unsuitable for intraocular lens implantation; (3) Patients with systemic diseases cannot tolerate surgery; (4) Patients with incomplete follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Wen Xu, 13858185223, xuwen2003@zju.edu.cn
About this study
In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL calculation formulas.
- Being tested
- Several Calculation Formulas of Intraocular Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Several Calculation Formulas of Intraocular LensOther
Comparison of the accuracy of several intraocular lens calculation formulas
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute error
The Friedman test was applied to compare the median absolute error between the formulas after the zeroing of the mean numerical error.
Post hoc analysis and Bonferroni correction was performed for multiple comparisons.
Measured: 1 week、1 month and 3 months postoperation
Secondary outcomes (1)
Distribution of error within ± 0.25D, ± 0.5D, ± 0.75D,and ± 1.0D
Frequency comparisons were made with the chi-square test
Measured: 1 week、1 month and 3 months postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Accuracy of Intraocular Lens Calculation FormulaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Xu, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672693
- Sponsor's protocol ID
- 2022-1059
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Accuracy of Intraocular Lens Calculation Formula
- ClinicalTrials.gov ID
- NCT05672693
- Acronym / sponsor ID
- 2022-1059
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jan 2023 (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.
In this study, we will retrospectively collect patients who have performed phacoemulsification combined with intraocular lens implantation in our hospital, collect various preoperative biometric data and postoperative refractive data of patients, conduct statistical analysis, and compare the accuracy of various IOL calculation formulas.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were previously diagnosed as "senile cataract" in the Ophthalmology Center of the Second Affiliated Hospital of Zhejiang University Medical College and who performed "phacoemulsification cataract extraction combined with intraocular lens implantation"
Key inclusion criteria (1 listed)
- (1) Conform to the diagnosis of cataract; (2) No complications occurred during and after operation; (3) Before and after operation, the measurement of ocular biological characteristics and refractive state can be successfully completed; (4) Patients who can be followed up regularly after operation.
Key exclusion criteria (1 listed)
- (1) Serious intraoperative or postoperative complications; (2) Complicated with other eye diseases unsuitable for intraocular lens implantation; (3) Patients with systemic diseases cannot tolerate surgery; (4) Patients with incomplete follow-up data.
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 |
|---|---|---|
| Several Calculation Formulas of Intraocular LensComparison of the accuracy of several intraocular lens calculation formulas | Other | – |
Primary outcome
Mean absolute error
Time frame: 1 week、1 month and 3 months postoperation
The Friedman test was applied to compare the median absolute error between the formulas after the zeroing of the mean numerical error. Post hoc analysis and Bonferroni correction was performed for multiple comparisons.
1 secondary outcome
Distribution of error within ± 0.25D, ± 0.5D, ± 0.75D,and ± 1.0D
Time frame: 1 week、1 month and 3 months postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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.
Wen Xu study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 the Accuracy of Intraocular Lens Calculation Formula, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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 5 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu, PHD (13858185223, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error (time frame: 1 week、1 month and 3 months postoperation). 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 5 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.