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CompletedNCT01666821Updated Aug 16, 2012

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

An observational study in Geographic Atrophy, Wet Macular Degeneration and Retinal Drusen, sponsored by Shanghai University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-16.

Sponsored by Shanghai University of Traditional Chinese Medicine · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
59
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Geographic Atrophy
  • Wet Macular Degeneration
  • Retinal Drusen

Keywords

  • macular degeneration; choroidal neovascularization
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 59 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants gave written informed consent, and this study was approved by the local Ethics Committee in accordance with the Helsinki Declaration.

Inclusion criteria

  • adults citizens aged above 45 years

Exclusion criteria

Exclusion Criteria:

  • lost samples
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
59 participants (actual)

Groups and cohorts

  • early and intermediate-stage AMD

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

    Other: Follow-up observation

Interventions

  • OtherFollow-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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: May 2004-September 2008

07

Study locations

1 site
  • Youyi Street
    Shanghai, Baoshan District 201900, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01666821
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Responsible party
Jun Hu (Department of ophthalmology, Shuguang hospital(Baoshan branch),Shanghai University of TCM, Shanghai University of Traditional Chinese Medicine) — Principal investigator
First posted
Aug 16, 2012
Start date
May 2004
Primary completion
Sep 2008
Completion
Jan 2009
Last update
Aug 16, 2012

Study contacts

zhao jie, master
principal investigator · Director of ophthalmology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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