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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03593824
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
23
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: bilateral cataract removal surgery for dense cataract
  • Procedure: bilateral cataract removal surgery for non-dense nuclear cataract
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Susceptibility of Phenotypic Plasticity During Adversity and Prosperity in Infants With Visual Deprivation
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

ArmIntervention/Treatment
Experimental: dense cataract group

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.

Experimental: non-dense nuclear cataract group

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Zhongshan Ophthalmic CenterGuangzhouGuangdongChina510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Haotian Lin, Ophthalmologist, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03593824
Other Study ID Numbers:
  • CCPMOH2018-China-6
First Posted:
Jul 20, 2018
Last Update Posted:
Jul 20, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haotian Lin, Ophthalmologist, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2018