Clinical trial NCT02761850: Developmental Profile of Ocular Refraction in Patients With Congenital Cataract
Official title: Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
First posted: 2016-05-04
Enrollment: 1164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CC were enrolled from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH). The study involved 1,164 participants (6,585 persontimes) enrolled from Jan 2010 to Oct 2015. Cataract removal and/or intraocular lens (IOL) implantation were conducted by two experienced cataract surgeons for participants.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Children with uncomplicated surgeries
* Children with unilateral/bilateral cataract

Exclusion Criteria:

* Corneal diseases
* Lens luxation
* Glaucoma
* Retinal diseases
* Nystagmus and nanophthalmos

Primary outcomes:
measure: The refraction status (presented as spherical equivalent, SE)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D., Ph.D
role: STUDY_CHAIR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, M.D., Ph.D
role: STUDY_DIRECTOR
References:
citation: 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. No abstract available.