A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population

Geographic Atrophy Clinical Trial

Official title:

A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666821
• Other study ID #: 04-E-1
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 14, 2012
• Start date: May 2004
• Est. completion date: January 2009

Study information

• Verified date: August 2012
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.

Description:

This population-based study enrolled 59 patients (>45 years old; 70 eyes) with early and intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive standardized ophthalmic examinations included visual acuity, anterior segment analysis by slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early and intermediate-stage AMD patients were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• adults citizens aged above 45 years

Exclusion Criteria:

• lost samples

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Geographic Atrophy
• Macular Degeneration
• Neovascularization, Pathologic
• Retinal Drusen
• Wet Macular Degeneration

Intervention

Other:
• Follow-up observation
a epidemiologic survey of ocular diseases in an adult population (>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations

Locations

Country	Name	City	State
China	Youyi Street	Shanghai	Baoshan District

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the early and intermediate-stage AMD	Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.	May 2004-September 2008	Yes