High MyopiaNCT03062085
Shanghai High Myopia Study
An observational study of High Myopia and Cataract, run by Shanghai High Myopia Study Group at 1 site in China.
Trial summary
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- High Myopia, Cataract, Visual Outcome
- What is being tested?
- Cataract
- How many people
- 60,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2045
- How long will I take part?
- 5 Years
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.
Who may be able to join
- Clinical diagnosis of cataract
- Must be able to cooperate with the ophthalmic examination
Who cannot join
- Clinical diagnosis of mental illness
- Mentally disabled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Yi Lu, M.D., (86)021-64377134, luyieent@163.com
About this study
Official title: Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.
Read the detailed description
High myopic cataract (HMC) has become a major high-risky type of cataract in China, which accounts for nearly 30% of cataract in recent years. Compared to age-related cataract, HMC is characterized with earlier onset, severer lens opacities, higher incidence of vitreoretinopathy and postoperative complications compared to age-related cataract(ARC).
The main purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, when compared to those age-matched ARC patients.
On the other hand, due to the lack of research in the pathogenesis of HMC, it is difficult for the investigators to precisely evaluate its risk and prognosis, and to improve its prevention and treatment. The previous study of investigators majored in a large-sample analysis on the clinical features and related genes of HMC. After preliminary screening, eight genes were selected for further investigation: 1) genes related to pathogenesis of HMC: CRYAA/ GSTP1/ TXNRD2;2) genes related to vitreoretinopathy: MCP1/ VEGFA/ CFH; 3) genes related to postoperative complications: TGFB2/ CERS2. In the present study, in order to establish a risk model of HMC from the aspect of precision medicine, the investigators are preparing to set up a comprehensive clinical database for further sequencing of selected genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale, to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of HMC.
The research aim to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, to thoroughly illustrate the influence of HMC-related genes to its prognosis and to elucidate the pathogenesis of HMC, for further promotion in the disease prevention and prognosis as well.
- Conditions
- High Myopia, Cataract, Visual Outcome, Genetic Anticipation
- Being tested
- Cataract
- Medical subject headings
- Cataract, Anticipation, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CataractOther
The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.
| Study group | Role | What they receive |
|---|---|---|
| High myopic cataract group | Cataract patients with high myopia. Receives: Other: Cataract | |
| Age-related cataract group | Age-related cataract patients. Receives: Other: Cataract | |
| Ametropic cataract group | Cataract patients with ametropia. Receives: Other: Cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients
Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Measured: Follow-up until five years after surgery
Differences in the clinical phenotypes and visual outcomes of age-related cataract patients
Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Measured: Follow-up until five years after surgery
Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients
Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Measured: Follow-up until five years after surgery
Secondary outcomes (1)
Genetic diversity based on biological specimen samples of three groups
Sequencing of selected genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of HMC, compared to age-related cataract and ametropic cataract patients.
Measured: Analyzed within six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2015
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for High MyopiaStudies 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
- Prospective
- Enrolment
- 60,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai High Myopia Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Yi Lu, M.D., Study chair, Eye & ENT Hospital of Fudan UniversityXiangjia Zhu, M.D., Study director, Eye & ENT Hospital of Fudan UniversityKeke Zhang, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityWenwen He, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityYu Du, B.S., Principal investigator, Eye & ENT Hospital of Fudan UniversityYinglei Zhang, M.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityZhennan Zhao, Ph.D., Principal investigator, Eye & ENT Hospital of Fudan UniversityRuiqi Chang, B.S., Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062085
- Sponsor's protocol ID
- NSFC-81670835
- Status last verified
- May 2026
- First submitted
- 23 Jan 2017
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided.
Publications
Zhang Y, Zhang S, Zhang K, Lu Y, Zhu X. Characteristics of the Corneal Endothelium in Elderly Adults with High Myopia. Phenomics. 2025 Jan 27;4(6):562-569. doi: 10.1007/s43657-024-00186-6. eCollection 2024 Dec.
PubMed 40061825Hu X, Qi J, Cheng K, He W, Zhang K, Zhao C, Lu Y, Zhu X. Effectiveness of prophylactic capsular tension ring implantation during cataract surgery in highly myopic eyes. J Cataract Refract Surg. 2024 Oct 1;50(10):1030-1036. doi: 10.1097/j.jcrs.0000000000001495.
PubMed 39313860He W, Wei L, Liu S, Huang Z, Qi J, Zhang K, Meng J, Du Y, Lu Y, Zhu X. Role of Optic Nerve Head Characteristics in Predicting Intraocular Pressure Spikes after Cataract Surgery in Highly Myopic Eyes. Ophthalmol Ther. 2023 Aug;12(4):2023-2033. doi: 10.1007/s40123-023-00714-z. Epub 2023 May 13.
PubMed 37178442He W, Cheng K, Zhao L, Liu S, Huang Z, Zhang K, Du Y, Zhou X, Lu Y, Zhu X. Long-Term Outcomes of Posterior Capsular Opacification in Highly Myopic Eyes and Its Influencing Factors. Ophthalmol Ther. 2023 Aug;12(4):1881-1891. doi: 10.1007/s40123-023-00711-2. Epub 2023 May 3.
PubMed 37138195Meng J, Chen Y, Cheng K, Qi J, Du Y, Yao Y, He W, Zhang K, Lu Y, Zhu X. LONG-TERM PROGRESSION PATTERN OF MYOPIC TRACTIONAL MACULOPATHY: Outcomes and Risk Factors. Retina. 2023 Jul 1;43(7):1189-1197. doi: 10.1097/IAE.0000000000003791.
PubMed 36977327Lu Q, He W, Qian D, Lu Y, Zhu X. Measurement of crystalline lens tilt in high myopic eyes before cataract surgery using swept-source optical coherence tomography. Eye Vis (Lond). 2020 Mar 6;7:14. doi: 10.1186/s40662-020-00176-5. eCollection 2020.
PubMed 32161773
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcome Evaluation and Genetic Analysis: Shanghai High Myopia Study
- ClinicalTrials.gov ID
- NCT03062085
- Acronym / sponsor ID
- NSFC-81670835
- Conditions
- High Myopia, Cataract, Visual Outcome, Genetic Anticipation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Shanghai High Myopia Study GroupUniversity, hospital or other
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2045 (estimated)
- First posted
- 23 Feb 2017 (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 purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.
Detailed description
High myopic cataract (HMC) has become a major high-risky type of cataract in China, which accounts for nearly 30% of cataract in recent years. Compared to age-related cataract, HMC is characterized with earlier onset, severer lens opacities, higher incidence of vitreoretinopathy and postoperative complications compared to age-related cataract(ARC).
The main purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, when compared to those age-matched ARC patients.
On the other hand, due to the lack of research in the pathogenesis of HMC, it is difficult for the investigators to precisely evaluate its risk and prognosis, and to improve its prevention and treatment. The previous study of investigators majored in a large-sample analysis on the clinical features and related genes of HMC. After preliminary screening, eight genes were selected for further investigation: 1) genes related to pathogenesis of HMC: CRYAA/ GSTP1/ TXNRD2;2) genes related to vitreoretinopathy: MCP1/ VEGFA/ CFH; 3) genes related to postoperative complications: TGFB2/ CERS2. In the present study, in order to establish a risk model of HMC from the aspect of precision medicine, the investigators are preparing to set up a comprehensive clinical database for further sequencing of selected genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale, to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of HMC.
The research aim to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, to thoroughly illustrate the influence of HMC-related genes to its prognosis and to elucidate the pathogenesis of HMC, for further promotion in the disease prevention and prognosis as well.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High myopic cataract group | – | Other: CataractCataract patients with high myopia. |
| Age-related cataract group | – | Other: CataractAge-related cataract patients. |
| Ametropic cataract group | – | Other: CataractCataract patients with ametropia. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.
Key inclusion criteria (2 listed)
- Clinical diagnosis of cataract
- Must be able to cooperate with the ophthalmic examination
Key exclusion criteria (2 listed)
- Clinical diagnosis of mental illness
- Mentally disabled
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 |
|---|---|---|
| CataractThe genetic and environmental factors concerning to the pathogenesis of cataract in the three groups. | Other | Age-related cataract group, Ametropic cataract group, High myopic cataract group |
Primary outcome
Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients
Time frame: Follow-up until five years after surgery
Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Differences in the clinical phenotypes and visual outcomes of age-related cataract patients
Time frame: Follow-up until five years after surgery
Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients
Time frame: Follow-up until five years after surgery
Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
1 secondary outcome
Genetic diversity based on biological specimen samples of three groups
Time frame: Analyzed within six months after surgery
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 11 May 2026.
- Derived from this study: PubMed 40061825Zhang Y, Zhang S, Zhang K, Lu Y, Zhu X. Characteristics of the Corneal Endothelium in Elderly Adults with High Myopia. Phenomics. 2025 Jan 27;4(6):562-569. doi: 10.1007/s43657-024-00186-6. eCollection 2024 Dec.
- Derived from this study: PubMed 39313860Hu X, Qi J, Cheng K, He W, Zhang K, Zhao C, Lu Y, Zhu X. Effectiveness of prophylactic capsular tension ring implantation during cataract surgery in highly myopic eyes. J Cataract Refract Surg. 2024 Oct 1;50(10):1030-1036. doi: 10.1097/j.jcrs.0000000000001495.
- Derived from this study: PubMed 37178442He W, Wei L, Liu S, Huang Z, Qi J, Zhang K, Meng J, Du Y, Lu Y, Zhu X. Role of Optic Nerve Head Characteristics in Predicting Intraocular Pressure Spikes after Cataract Surgery in Highly Myopic Eyes. Ophthalmol Ther. 2023 Aug;12(4):2023-2033. doi: 10.1007/s40123-023-00714-z. Epub 2023 May 13.
- Derived from this study: PubMed 37138195He W, Cheng K, Zhao L, Liu S, Huang Z, Zhang K, Du Y, Zhou X, Lu Y, Zhu X. Long-Term Outcomes of Posterior Capsular Opacification in Highly Myopic Eyes and Its Influencing Factors. Ophthalmol Ther. 2023 Aug;12(4):1881-1891. doi: 10.1007/s40123-023-00711-2. Epub 2023 May 3.
- Derived from this study: PubMed 36977327Meng J, Chen Y, Cheng K, Qi J, Du Y, Yao Y, He W, Zhang K, Lu Y, Zhu X. LONG-TERM PROGRESSION PATTERN OF MYOPIC TRACTIONAL MACULOPATHY: Outcomes and Risk Factors. Retina. 2023 Jul 1;43(7):1189-1197. doi: 10.1097/IAE.0000000000003791.
- Derived from this study: PubMed 32161773Lu Q, He W, Qian D, Lu Y, Zhu X. Measurement of crystalline lens tilt in high myopic eyes before cataract surgery using swept-source optical coherence tomography. Eye Vis (Lond). 2020 Mar 6;7:14. doi: 10.1186/s40662-020-00176-5. eCollection 2020.
- Individual participant dataSharing planned: Undecided. 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.
Yi Lu, M.D. study chair
Eye & ENT Hospital of Fudan University
Xiangjia Zhu, M.D. study director
Eye & ENT Hospital of Fudan University
Keke Zhang, M.D. principal investigator
Eye & ENT Hospital of Fudan University
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 High Myopia and Cataract, run by Shanghai High Myopia Study Group 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
Contact Yi Lu, M.D. ((86)021-64377134, luyieent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients (time frame: Follow-up until five 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?
On the ClinicalTrials.gov record for NCT03062085, which also lists 6 linked publications.
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 11 May 2026.