The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts

Cataract Clinical Trial

Official title:

The Susceptibility of Phenotypic Plasticity During Adversity and Prosperity in Infants With Visual Deprivation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593824
• Other study ID #: CCPMOH2018-China-6
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phenotypic plasticity is the ability of individuals to change their phenotypic status when exposed to environmental variations. However, whether the plastic changes show differential susceptibility in adversity and prosperity is debated and the specific pattern of plasticity remains elusive.

Here the investigators address this question by tracking the phenotypes (functional, structural, physical, and attachment traits) in two groups of infants before and after visual deprivation: one group experienced a short duration of complete deprivation (extreme adversity) and the other group experienced a long durations of partial deprivation (watered-down adversity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis with dense or non-dense nuclear congenital cataract

Exclusion Criteria:

• no metabolic diseases, mental retardation or central nervous diseases

• had no history of inherited diseases

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• bilateral cataract removal surgery for dense cataract
Participants were born with dense bilateral cataracts (extreme adversity) will undergo surgery for bilateral cataract removal at an early age, mostly around 3 months of age.
• bilateral cataract removal surgery for non-dense nuclear cataract
Participants were born with non-dense and nuclear bilateral cataracts (watered-down adversity) will undergo cataract removal surgery bilaterally in a compromised timing, mostly around one year old.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Ellis BJ, Boyce WT, Belsky J, Bakermans-Kranenburg MJ, van Ijzendoorn MH. Differential susceptibility to the environment: an evolutionary--neurodevelopmental theory. Dev Psychopathol. 2011 Feb;23(1):7-28. doi: 10.1017/S0954579410000611. — View Citation

Pluess M, Belsky J. Vantage sensitivity: individual differences in response to positive experiences. Psychol Bull. 2013 Jul;139(4):901-16. doi: 10.1037/a0030196. Epub 2012 Oct 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in visual acuity measured by Teller visual acuity cards		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Secondary	Change from baseline in refractive status measured by autorefractor and objective retinoscopy		1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery