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

NCT03593824 | Completed DMC

• 1 other identifier: CCPMOH2018-China-6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cataract

Keywords

Phenotypic plasticity; Adversity; Prosperity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

dense cataract group

EXPERIMENTAL

Procedure: bilateral cataract removal surgery for dense cataract

non-dense nuclear cataract group

EXPERIMENTAL

Procedure: bilateral cataract removal surgery for non-dense nuclear cataract

Interventions

bilateral cataract removal surgery for dense cataract PROCEDURE

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.

dense cataract group

bilateral cataract removal surgery for non-dense nuclear cataract PROCEDURE

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.

non-dense nuclear cataract group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis with dense or non-dense nuclear congenital cataract

You may not qualify if:

• no metabolic diseases, mental retardation or central nervous diseases
• had no history of inherited diseases

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related 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.

  PMID: 21262036 BACKGROUND

• 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.

  PMID: 23025924 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Haotian Lin

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

CN (1)