Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

Cataract Clinical Trial

Official title:

Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761850
• Other study ID #: CCPMOH2016-China-2
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: May 4, 2016
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

Description:

The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized.

The investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1164
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children with uncomplicated surgeries

• Children with unilateral/bilateral cataract

Exclusion Criteria:

• Corneal diseases

• Lens luxation

• Glaucoma

• Retinal diseases

• Nystagmus and nanophthalmos

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (1)

Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The refraction status (presented as spherical equivalent, SE)	Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.	Baseline	No

External Links

•   Home page of Zhongshan Ophthalmic Center