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

July 10, 2018 updated by: Haotian Lin, Sun Yat-sen University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (ACTUAL)

July 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2018-China-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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