Birth Year-dependent Eye Parameters ChangeNCT06126302
Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China
An observational study of Birth Year-dependent Eye Parameters Change, run by Min Ke.
Trial summary
The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data from patients of four hospital. Read more about this study
- Who is it for?
- Ages 7 to 130 years
- Conditions the study is for
- Birth Year-dependent Eye Parameters Change
- What is being tested?
- Birth year
- How many people
- 60,000 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2023to 20 Nov 2023
- 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 7 to 130 years
- All sexes
- Child, Adult, Older adult
Study population: Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October 2023.
Who may be able to join
- Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October 2023. Only patients who would cooperate with examinations to ensure stable and repeatable data (AL was measured 5 times or more, CC was measured 3 times or more, and the coefficient of variation of the measured results were≤15%a coefficient of variation ≤15% was considered low variation) were selected.
Who cannot join
- Severe systemic disease, corneal diseases, severe dry eyes, serious fundus disease, noticeable lesions of the refractive stroma, inability to cooperate, or poor measurement quality (coefficient of variation> 15%) were the exclusion criteria.
About this study
Official title: Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China From the Perspective of Birth Year
The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data from patients of four hospital. The trends in the axial length and corneal curvature will be observed.
Read the detailed description
The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data between 2012 and 2023. There were four clinical centers involved in this study. The study was approved by the Medical Ethics Committee of Zhongnan Hospital, Wuhan University, Yichang center hospital, Jingzhou center hospital , Yichang center hospital and Xiaogan center hospital, and conformed to the tenets of the Declaration of Helsinki. We divided the participants into ten groups of 10 years each based on their year of birth (called birth decade) and observed the trends in the axial length and corneal curvature in different groups.
- Being tested
- Birth year
- Keywords
- Eye axial length, Corneal curvature, Birth year-dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth yearOther
we divided the patients according to patients' birth year
| Study group | Role | What they receive |
|---|---|---|
| Before 1930 | the patients were divided into ten groups according to the decade of their birth: before 1930 Receives: Other: Birth year | |
| 1930-1939 | the patients were divided into ten groups according to the decade of their birth: 1930-1939 Receives: Other: Birth year | |
| 1940-1949 | the patients were divided into ten groups according to the decade of their birth: 1940-1949 Receives: Other: Birth year | |
| 1950-1959 | the patients were divided into ten groups according to the decade of their birth: 1950-1959 Receives: Other: Birth year | |
| 1960-1969 | the patients were divided into ten groups according to the decade of their birth: 1960-1969 Receives: Other: Birth year | |
| 1970-1979 | the patients were divided into ten groups according to the decade of their birth: 1970-1979 Receives: Other: Birth year | |
| 1980-1989 | the patients were divided into ten groups according to the decade of their birth: 1980-1989 Receives: Other: Birth year | |
| 1990-1999 | the patients were divided into ten groups according to the decade of their birth: 1990-1999 Receives: Other: Birth year | |
| 2000-2009 | the patients were divided into ten groups according to the decade of their birth: 2000-2009 Receives: Other: Birth year | |
| after 2009 | the patients were divided into ten groups according to the decade of their birth: after 2009 Receives: Other: Birth year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Axial Length
The Axial length of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia).AL was measured as the distance from the tear film to the retinal pigment epithelium. The mean of 5 measurements wasas taken for final analyses.
Measured: 2023/10
Corneal Curvature
The corneal curvature of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia). Corneal curvature was measured in two meridians: flat keratometry (K1) and steep K (K2). The K value was the mean of K1 and K2. Corneal curvature was measured at least three times. In case of variations in values, measurements were repeated until reproducible results were obtained.
Measured: 2023/10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start5 Nov 2023 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth Year-dependent Eye Parameters ChangeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Ke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Ke, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126302
- Sponsor's protocol ID
- 20231105
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Changes in Eye Axis Length and Corneal Curvature in Central China From the Perspective of Birth Year
- ClinicalTrials.gov ID
- NCT06126302
- Acronym / sponsor ID
- 20231105
- Keywords
- Eye axial length, Corneal curvature, Birth year-dependent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Min KeUniversity, hospital or other
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 13 Nov 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.
The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data from patients of four hospital. The trends in the axial length and corneal curvature will be observed.
Detailed description
The Chinese lifestyle has undergone dramatic changes over the past century. In recent years, limited studies reported the changing trend in crucial eye parameters of people born in different decades. This multicenter study analyzed the axial length and average corneal curvature data between 2012 and 2023. There were four clinical centers involved in this study. The study was approved by the Medical Ethics Committee of Zhongnan Hospital, Wuhan University, Yichang center hospital, Jingzhou center hospital , Yichang center hospital and Xiaogan center hospital, and conformed to the tenets of the Declaration of Helsinki. We divided the participants into ten groups of 10 years each based on their year of birth (called birth decade) and observed the trends in the axial length and corneal curvature in different groups.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Before 1930 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: before 1930 |
| 1930-1939 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1930-1939 |
| 1940-1949 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1940-1949 |
| 1950-1959 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1950-1959 |
| 1960-1969 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1960-1969 |
| 1970-1979 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1970-1979 |
| 1980-1989 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1980-1989 |
| 1990-1999 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 1990-1999 |
| 2000-2009 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: 2000-2009 |
| after 2009 | – | Other: Birth yearthe patients were divided into ten groups according to the decade of their birth: after 2009 |
Who may qualify
- Ages
- 7 to 130 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October 2023.
Key inclusion criteria (1 listed)
- Eligible patients were those aged ≥7 years and who underwent intraocular lens (IOL) Master (version 5.5) biometry for routine examination of cataract or refractive examination (ametropia and presbyopia) between April 2012 and November October 2023. Only patients who would cooperate with examinations to ensure stable and repeatable data (AL was measured 5 times or more, CC was measured 3 times or more, and the coefficient of variation of the measured results were≤15%a coefficient of variation ≤15% was considered low variation) were selected.
Key exclusion criteria (1 listed)
- Severe systemic disease, corneal diseases, severe dry eyes, serious fundus disease, noticeable lesions of the refractive stroma, inability to cooperate, or poor measurement quality (coefficient of variation> 15%) were the exclusion criteria.
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 |
|---|---|---|
| Birth yearwe divided the patients according to patients' birth year | Other | 1930-1939, 1940-1949, 1950-1959, 1960-1969, 1970-1979, 1980-1989, 1990-1999, 2000-2009, Before 1930, after 2009 |
Primary outcome
Eye Axial Length
Time frame: 2023/10
The Axial length of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia).AL was measured as the distance from the tear film to the retinal pigment epithelium. The mean of 5 measurements wasas taken for final analyses.
Corneal Curvature
Time frame: 2023/10
The corneal curvature of all patients were measured using the IOL Master 5.5 (Carl Zeiss Meditec, Dublin, CA) biometry system for routine examination of cataracts or refractive examination (ametropia and presbyopia). Corneal curvature was measured in two meridians: flat keratometry (K1) and steep K (K2). The K value was the mean of K1 and K2. Corneal curvature was measured at least three times. In case of variations in values, measurements were repeated until reproducible results were obtained.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Year-dependent Eye Parameters Change, run by Min Ke.
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 13 Nov 2023. 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?
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?
Eye Axial Length (time frame: 2023/10). 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 13 Nov 2023.