CataractNCT04340635
Multi-center Ocular Biological Parameters Study
An observational study of Cataract, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
This study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Select elderly cataract patients from different regions of China (at least one representative city in each of east, south, west, north, and central China) who were treated in Aier Eye Hospital.
Who may be able to join
- patients aged over 50 years
Who cannot join
- history of refractive surgery,
- corneal diseases
- ocular inflammation
- trauma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Aier Eye Hospital
Shanghai, Shanghai Municipality, 200000
xu chen, +8613601762646, Francois.chenxu@gmail.com
hui Liu, 18570638843, 1009254042@qq.com
About this study
Official title: Analysis of Eye Bioparametric Data of Chinese Population Based on Big Data
This study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population.
Read the detailed description
①Relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. Most of the studies that represent the biological characteristics of the general population in China and the differences in biological parameters at home and abroad are in the research process, or Semi-finished products.
②The investigators found in clinical observation that the eyeball biological data of the Chinese population may not be consistent with the foreign population.
③ This study is the first study of human eye biological parameters based on different regions of large-scale populations in China, which is of great significance for understanding the human eye structure in different regions of China.
- Conditions
- Cataract
- Keywords
- Corneal astigmatism, axial length (AL), anterior chamber depth (ACD), partial coherence interferometry
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Without intervention
| Study group | Role | What they receive |
|---|---|---|
| Multi-center data collection | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length (AL)
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Measured: 1 hour
anterior chamber depth (ACD)
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Measured: 1 hour
keratometric power (K)
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Measured: 1 hour
corneal astigmatism (CA)
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Jan 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (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 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
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340635
- Sponsor's protocol ID
- SHIRB2018020
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qian Z, Xie X, Yang J, Ye H, Wang Z, Chen J, Liu H, Liang J, Jiang L, Zheng C, Chen X. Detection of shallow anterior chamber depth from two-dimensional anterior segment photographs using deep learning. BMC Ophthalmol. 2021 Sep 22;21(1):341. doi: 10.1186/s12886-021-02104-0.
PubMed 34551738
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Eye Bioparametric Data of Chinese Population Based on Big Data
- ClinicalTrials.gov ID
- NCT04340635
- Acronym / sponsor ID
- SHIRB2018020
- Conditions
- Cataract
- Keywords
- Corneal astigmatism, axial length (AL), anterior chamber depth (ACD), partial coherence interferometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Apr 2020 (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 study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population.
Detailed description
①Relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. Most of the studies that represent the biological characteristics of the general population in China and the differences in biological parameters at home and abroad are in the research process, or Semi-finished products.
②The investigators found in clinical observation that the eyeball biological data of the Chinese population may not be consistent with the foreign population.
③ This study is the first study of human eye biological parameters based on different regions of large-scale populations in China, which is of great significance for understanding the human eye structure in different regions of China.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-center data collection | – | –Without intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Select elderly cataract patients from different regions of China (at least one representative city in each of east, south, west, north, and central China) who were treated in Aier Eye Hospital.
Key inclusion criteria (1 listed)
- patients aged over 50 years
Key exclusion criteria (4 listed)
- history of refractive surgery,
- corneal diseases
- ocular inflammation
- trauma
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 |
|---|---|---|
| Without intervention | Other | Multi-center data collection |
Primary outcome
axial length (AL)
Time frame: 1 hour
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
anterior chamber depth (ACD)
Time frame: 1 hour
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
keratometric power (K)
Time frame: 1 hour
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
corneal astigmatism (CA)
Time frame: 1 hour
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 34551738Qian Z, Xie X, Yang J, Ye H, Wang Z, Chen J, Liu H, Liang J, Jiang L, Zheng C, Chen X. Detection of shallow anterior chamber depth from two-dimensional anterior segment photographs using deep learning. BMC Ophthalmol. 2021 Sep 22;21(1):341. doi: 10.1186/s12886-021-02104-0.
- Individual participant dataSharing planned: Undecided
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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.
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 Aier School of Ophthalmology, Central South 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 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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 xu chen (13601762646, Francois.chenxu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axial length (AL) (time frame: 1 hour). 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 NCT04340635, 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 9 Apr 2020.