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Completed

NCT Number: NCT03593824

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

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).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2018
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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