NCT02765230

Brief Summary

The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
2 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
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 3, 2016

Last Update Submit

May 5, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam

    The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.

    Baseline

  • Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards

    The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).

    Baseline

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All of the registered children of CCPMOH were diagnosed by anterior segmental photography to confirm the morphology, location, and degree of cataract after pupil dilation. Fifty-three pediatric patients (53 cataract eyes and 53 contralateral normal eyes) with uncomplicated unilateral total cataract were selected 3 months after surgery from the CCPMOH.

You may qualify if:

  • Children with uncomplicated surgeries
  • Children who were younger than 10 years old
  • Children with unilateral total cataract

You may not qualify if:

  • Premature birth
  • Microphthalmia
  • Micro-or Megalocornea
  • Keratoconus
  • Glaucoma
  • Traumatic or complicated cataracts
  • Vitreous and retinal diseases
  • Any previous surgeries

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 (3)

  • Hutcheson KA. Application of new ophthalmic technology in the pediatric patient. Curr Opin Ophthalmol. 2007 Sep;18(5):384-91. doi: 10.1097/ICU.0b013e328244e07e.

    PMID: 17700231BACKGROUND
  • Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.

    PMID: 22921386BACKGROUND
  • Long E, Chen J, Liu Z, Lin Z, Cao Q, Zhang X, Li X, Luo L, Lin H, Chen W, Liu Y. Interocular anatomical and visual functional differences in pediatric patients with unilateral cataracts. BMC Ophthalmol. 2016 Nov 3;16(1):192. doi: 10.1186/s12886-016-0371-5.

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.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
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 6, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations