Evaluation of Refractive Status and Ophthalmological Problems of Prematurity

NCT01045616 | Completed DMC

• 1 other identifier: 200806070R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Children born with very low birth weight and extremely low birth weight are at increased risk of various ophthalmic challenges such as retinopathy of prematurity (ROP), refractive error, strabismus, cerebral visual impairment, colour vision deficits, reduced contrast sensitivity (CS), visual field defects, and decreased visual acuity (VA). Many of these factors are not independent of each other. Among them, refractive error is a really common disorder. These can cause significant disability which can impact life's activities and, qualities. Currently, no standard guidelines are available toward the provision of ophthalmic follow up care for preterm infants. It is important to survey the prevalence of different ophthalmic sequelae in Taiwan, to identify the risk factors of developing these sequelae, and, furthermore, to build up a screening program. The preterm population has heterogeneous conditions to developing ophthalmic sequelae. National Taiwan University Hospital (NTUH) is now in charge of a big part of intense care for these low birth weight preterm neonates. With detailed medical record done of these children during care in the neonatal unit, we are competence for this meaningful program.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

• The refractive status of these children born prematurely

  from 2008/7 - 2009/12

Secondary Outcomes (1)

• other ophthalmological problems of these children born prematurely

  from 2008-7 to 2009-12

Study Arms (1)

Prematurity

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with premature birth history born between January 1, 1999 and December 30, 2001 in National Taiwan University Hospital

You may qualify if:

• (1) born at post-conception age of less than 35 weeks or with birth weight of less than 1500 gm.
• (2) complete medical records and ophthalmic records available

You may not qualify if:

• if unable to communicate or have ophthalmological examinations done due to cognitive defect.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chen TC, Tsai TH, Shih YF, Yeh PT, Yang CH, Hu FC, Lin LL, Yang CM. Long-term evaluation of refractive status and optical components in eyes of children born prematurely. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6140-8. doi: 10.1167/iovs.10-5234. Epub 2010 Aug 4.

  PMID: 20688740 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• CHUNG-MAY YANG, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Tzu-Hsun Tsai, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Ta-Ching Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 11, 2010

Record last verified: 2010-01

Locations

TW (1)