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

August 14, 2012 updated by: Jun Hu, Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Baoshan District
      • Shanghai, Baoshan District, China, 201900
        • Youyi Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • adults citizens aged above 45 years

Exclusion Criteria:

  • lost samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the early and intermediate-stage AMD
Time Frame: 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.
May 2004-September 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: zhao jie, master, Director of ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-E-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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