CataractNCT03907358
The Pathogenesis of Human Senile Cataract
An observational study of Cataract, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics. Read more about this study
- Who is it for?
- Ages 5 to 94 years
- Conditions the study is for
- Cataract
- What is being tested?
- phacoemulsification
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2016to 30 Jun 2020
- How long will I take part?
- 3 Months
- 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 5 to 94 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.
Who may be able to join
- Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.
Who cannot join
- Patients whose cataracts need not be operated
- Patients with any contraindications to cataract surgery
- Patients are unwilling to undergo cataract surgery
Trial locations and contacts
1 site in 1 country.
Bijun Zhu contact
China1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, 200080
Haidong Zou, Dr., 86-21-63240090 ext. 6833, zouhaidong@hotmail.com
About this study
Official title: The Pathogenesis of Age-related Cataract
To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.
Read the detailed description
Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.
- Conditions
- Cataract
- Being tested
- phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cataract in old age | Not described Receives: Procedure: phacoemulsification | |
| cataract in young age | Not described Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of miRNA in micro-scale human aqueous humor
method development for miRNA detection in aqueous humor
Measured: 12 month
Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples
low-cell-number epigenome profiling for study of cataract
Measured: 24 month
Study of cataract by genomics, transcriptomics, and proteomics approaches
detect histone H3 lysine 4 trimethylation (H3K4me3) of aqueous humor of cataract patients by genomics, transcriptomics, and proteomics methods
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start7 Dec 2016
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (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.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Zou, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907358
- Sponsor's protocol ID
- Shanghai1st-cataract-001
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenesis of Age-related Cataract
- ClinicalTrials.gov ID
- NCT03907358
- Acronym / sponsor ID
- Shanghai1st-cataract-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Apr 2019 (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.
To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.
Detailed description
Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cataract in old age | – | Procedure: phacoemulsification |
| cataract in young age | – | Procedure: phacoemulsification |
Who may qualify
- Ages
- 5 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.
Key inclusion criteria (1 listed)
- Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.
Key exclusion criteria (3 listed)
- Patients whose cataracts need not be operated
- Patients with any contraindications to cataract surgery
- Patients are unwilling to undergo cataract 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 |
|---|---|---|
| phacoemulsification | Procedure or surgery | cataract in old age, cataract in young age |
Primary outcome
Characterization of miRNA in micro-scale human aqueous humor
Time frame: 12 month
method development for miRNA detection in aqueous humor
Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples
Time frame: 24 month
low-cell-number epigenome profiling for study of cataract
Study of cataract by genomics, transcriptomics, and proteomics approaches
Time frame: 36 month
detect histone H3 lysine 4 trimethylation (H3K4me3) of aqueous humor of cataract patients by genomics, transcriptomics, and proteomics methods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- 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.
Bijun Zhu contact
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 Shanghai General Hospital, Shanghai Jiao Tong 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 3 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 2019. 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 Haidong Zou (86-21-63240090 ext. 6833, zouhaidong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of miRNA in micro-scale human aqueous humor (time frame: 12 month). 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?
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 2019.