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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jun Hu, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01666821
First received: August 14, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Geographic Atrophy
Wet Macular Degeneration
Retinal Drusen
 Other: Follow-up observation

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • change of the early and intermediate-stage AMD [ Time Frame: May 2004-September 2008 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 59
Study Start Date: May 2004
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • adults citizens aged above 45 years

Exclusion Criteria:

  • lost samples
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666821

Locations
China, Baoshan District
Youyi Street
Shanghai, Baoshan District, China, 201900
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Principal Investigator: zhao jie, master Director of ophthalmology
  More Information

No publications provided

Responsible Party: Jun Hu, Department of ophthalmology, Shuguang hospital(Baoshan branch),Shanghai University of TCM, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01666821     History of Changes
Other Study ID Numbers: 04-E-1
Study First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai University of Traditional Chinese Medicine:
macular degeneration; choroidal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Drusen
Atrophy
Choroidal Neovascularization
Geographic Atrophy
Wet Macular Degeneration
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Pathological Conditions, Anatomical
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 19, 2013