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Clinical Research on Retinal Neovascularization of Diabetic Retinopathy

Primary Purpose

The Mechanism of Retinal Neovascularization of Diabetic, Retinopathy.

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
genetic analyzer
Sponsored by
Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for The Mechanism of Retinal Neovascularization of Diabetic

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • T2DM was diagnosed according to the World Health Organization Expert Consultation Report 1999 and consisted of one of the following: fasting blood glucose (FBG) ≥7.0 mmol/L (≥126 mg/dL), blood glucose ≥11.1 mmol/L (≥200 mg/dL) 2 hours after an oral glucose tolerance test (OGTT); or a random blood glucose ≥11.1 mmol/L (≥200 mg/dL).
  • DR was clinically graded in accordance with the International Clinical Diabetic Retinopathy guidelines based on fundus fluorescence angiography.
  • All participants with PDR underwent a comprehensive dilated fundus examination to detect DR by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography.

Exclusion Criteria:

  • Patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.

Sites / Locations

  • Tianjin Eye Hospital, Clinical college of Ophthalmology ,Tianjin Medical Univercity

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Lifestyle counseling

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 26, 2010
Last Updated
October 26, 2010
Sponsor
Tianjin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01229540
Brief Title
Clinical Research on Retinal Neovascularization of Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Tianjin Medical University

4. Oversight

5. Study Description

Brief Summary
Retinal neovascularization of diabetic retinopathy might be associated with genetic risk factors and environmental risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Mechanism of Retinal Neovascularization of Diabetic, Retinopathy.

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
No Intervention
Intervention Type
Genetic
Intervention Name(s)
genetic analyzer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: T2DM was diagnosed according to the World Health Organization Expert Consultation Report 1999 and consisted of one of the following: fasting blood glucose (FBG) ≥7.0 mmol/L (≥126 mg/dL), blood glucose ≥11.1 mmol/L (≥200 mg/dL) 2 hours after an oral glucose tolerance test (OGTT); or a random blood glucose ≥11.1 mmol/L (≥200 mg/dL). DR was clinically graded in accordance with the International Clinical Diabetic Retinopathy guidelines based on fundus fluorescence angiography. All participants with PDR underwent a comprehensive dilated fundus examination to detect DR by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography. Exclusion Criteria: Patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.
Facility Information:
Facility Name
Tianjin Eye Hospital, Clinical college of Ophthalmology ,Tianjin Medical Univercity
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China

12. IPD Sharing Statement

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Clinical Research on Retinal Neovascularization of Diabetic Retinopathy

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