Back to resultsThe Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bilateral cataract removal surgery for dense cataract
bilateral cataract removal surgery for non-dense nuclear cataract
Sponsored by
About this trial
This is an interventional basic science trial for Cataract focused on measuring Phenotypic plasticity, Adversity, Prosperity
Eligibility Criteria
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
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dense cataract group
non-dense nuclear cataract group
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in visual acuity measured by Teller visual acuity cards
Secondary Outcome Measures
Change from baseline in refractive status measured by autorefractor and objective retinoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03593824
Brief Title
The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts
Official Title
The Susceptibility of Phenotypic Plasticity During Adversity and Prosperity in Infants With Visual Deprivation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Phenotypic plasticity, Adversity, Prosperity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dense cataract group
Arm Type
Experimental
Arm Title
non-dense nuclear cataract group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
bilateral cataract removal surgery for dense cataract
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
bilateral cataract removal surgery for non-dense nuclear cataract
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in visual acuity measured by Teller visual acuity cards
Time Frame
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Secondary Outcome Measure Information:
Title
Change from baseline in refractive status measured by autorefractor and objective retinoscopy
Time Frame
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21262036
Citation
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.
Results Reference
background
PubMed Identifier
23025924
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.
Results Reference
background
Learn more about this trial
The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts
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