NCT03907358

Brief Summary

To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

April 4, 2019

Last Update Submit

April 6, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

  • Characterization of miRNA in micro-scale human aqueous humor

    method development for miRNA detection in aqueous humor

    12 month

  • Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples

    low-cell-number epigenome profiling for study of cataract

    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

    36 month

Study Arms (2)

cataract in old age

Procedure: phacoemulsification

cataract in young age

Procedure: phacoemulsification

Interventions

phacoemulsificationPROCEDURE
cataract in old agecataract in young age

Eligibility Criteria

Age5 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients whose cataracts need not be operated
  • Patients with any contraindications to cataract surgery
  • Patients are unwilling to undergo cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

Haidong Zou

CONTACT

86-21-63240090zouhaidong@hotmail.com

Bijun Zhu

CONTACT

judyzhu52@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 9, 2019

Study Start

December 7, 2016

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

CN(1)