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)

Enrollment

Location

Arms

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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.

Arm

Intervention/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

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

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:

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

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510060

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:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Ophthalmologist, Sun Yat-sen University

Phenotypic plasticity

Adversity

Prosperity

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jul 20, 2018