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

Completed

• Conditions: Geographic Atrophy; Wet Macular Degeneration; Retinal Drusen
• Interventions: Other: Follow-up observation

• Registration Number: NCT01666821
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2008-09
• Study Completion: 2009-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• adults citizens aged above 45 years

Exclusion Criteria

• lost samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early and intermediate-stage AMD	Follow-up observation	Follow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD

Primary Outcome Measures

Name	Time	Method
change of the early and intermediate-stage AMD	May 2004-September 2008	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.

Trial Locations

Locations (1)

Youyi Street; 🇨🇳 Shanghai, Baoshan District, China