Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000440921
Ethics application status
Approved
Date submitted
23/04/2011
Date registered
29/04/2011
Date last updated
29/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
the level of inflammation in eye of Patient with Diabetic Retinopathy
Scientific title
Integrin CD18 Expression in Neutrophil Infiltrating the Vitreous Fluid in Patients with Diabetic Retinopathy
Secondary ID [1] 260058 0
Nil
Universal Trial Number (UTN)
U1111-1120-9662
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic retinopathy 265722 0
Condition category
Condition code
Eye 265865 265865 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 265889 265889 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Vitreous samples was collected during the process of regular vitrectomy and were immediately placed in ice, centrifuged and separated into supernatants and cellular components. Surface expression of CD18 on the neutrophil infiltrated in the samples was analyzed with the flow cytometer immediately
Intervention code [1] 264476 0
Not applicable
Comparator / control treatment
Vitreous samples were collected from idiopathic FTMH patients without diabetes(group A) , full thickness macular hole with diabetes (FTMH with diabetes, group B), non proliferative diabetic retinopathy (NPDR, group C), and proliferative diabetic retinopathy (PDR, group D).
Control group
Active

Outcomes
Primary outcome [1] 266632 0
Neutrophil and CD18 MCF of the vitreous samples from every group.The infiltrating of neutrophil and its surface level of CD18 were measured by flow cytometry.
Timepoint [1] 266632 0
baseline
Secondary outcome [1] 276111 0
Nil
Timepoint [1] 276111 0
Nil

Eligibility
Key inclusion criteria
To evaluated the levels of CD18 on the surface of neutrophil infiltrating the vitreous fluid in patients with full thickness macular hole without diabetes (FTMH without diabetes, group A), full thickness macular hole with diabetes (FTMH with diabetes, group B), non proliferative diabetic retinopathy (NPDR, group C), and proliferative diabetic retinopathy (PDR, group D).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for patients with CSMO were (i) posterior vitreous detachment diagnosed by the presence of a Weiss ring, (ii) macular traction as evidenced by retinal striae involving the foveal center, (iii) macular ischaemia as defined by an enlarged fovealar avascular zone (FAZ 41000 mm) or significant perifoveal capillary loss on fundus fluorescein angiography (FFA), and (iv) coexistent retinal disease.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3421 0
China
State/province [1] 3421 0

Funding & Sponsors
Funding source category [1] 264951 0
Hospital
Name [1] 264951 0
Xian NO.4 Hospital scientific funding
Country [1] 264951 0
China
Primary sponsor type
Individual
Name
Song Huping
Country
China
Secondary sponsor category [1] 264047 0
Individual
Name [1] 264047 0
Lei Chunling
Country [1] 264047 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 32532 0
Address 32532 0
Country 32532 0
Phone 32532 0
Email 32532 0
Contact person for public queries
Name 15779 0
Song Huping
Address 15779 0
Department of Ophthalmology, Xian NO.4 Hospital, Xian city,shaanxi province,710004.
Country 15779 0
China
Phone 15779 0
+86 29 87480682(for xian, china)
Email 15779 0
songhpxian@163.com
Contact person for scientific queries
Name 6707 0
Song Huping
Address 6707 0
Department of Ophthalmology, Xian NO.4 Hospital, Xian city,shaanxi province,710004.
Country 6707 0
China
Phone 6707 0
+86 29 87480682(for xian, china)
Email 6707 0
songhpxian@163.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.