NCT02761850

Brief Summary

The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,164

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

May 3, 2016

Last Update Submit

May 4, 2016

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • The refraction status (presented as spherical equivalent, SE)

    Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.

    Baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CC were enrolled from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH). The study involved 1,164 participants (6,585 persontimes) enrolled from Jan 2010 to Oct 2015. Cataract removal and/or intraocular lens (IOL) implantation were conducted by two experienced cataract surgeons for participants.

You may qualify if:

  • Children with uncomplicated surgeries
  • Children with unilateral/bilateral cataract

You may not qualify if:

  • Corneal diseases
  • Lens luxation
  • Glaucoma
  • Retinal diseases
  • Nystagmus and nanophthalmos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.

    PMID: 26339020BACKGROUND

Related Links

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Haotian Lin, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yizhi Liu, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

  • Weirong Chen, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

January 1, 2010

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

CN(1)