Trial Review

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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
Address
Department of Ophthalmology, Xian NO.4 Hospital, Xian city,shaanxi province,710004
Country
China
Secondary sponsor category [1] 264047 0
Individual
Name [1] 264047 0
Lei Chunling
Address [1] 264047 0
Department of Ophthalmology, Xian NO.4 Hospital, Xian city,shaanxi province, 710004,
Country [1] 264047 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Background 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).
Method Vitreous samples from twelve patients of group A representing controls were analyzed together with the vitreous samples of 12 patients of group B, 14 patients of group C and 19 patients of group D. The infiltrating of neutrophil and its surface level of CD18 were measured by flow cytometry. The level of CD18 was presented as the mean channel fluorescence (MCF) on a logarithmic scale.
Results Neutrophil were detected in none of the 12 vitreous samples from group A patients, in 6(50%) of the 12 vitreous samples from group B patients, in 9 (64%) of the 14 vitreous samples from group C patients and in 15(78%) of the 19 vitreous samples from group D patients. CD18 MCF on neutrophil from group B, C, and D were 2.978±1.446, 3.201±0.692, and 4.072±0.837, respectively. The difference among them was significant (F = 4.354, P = 0.021). Subjects with more severe DR were more likely to have a higher level of CD18 MCF (trend test, P = 0.007). The level of CD18 MCF was significantly associated with the development of DR not only by simple correlation analysis (r = 0.46,P = 0.005) but also by stepwise multiple linear regression analysis (beta = 0.147, P = 0.035). Other clinical parameters, including FPG, SBP, and HDLc, were also significantly associated with CD18 MCF by stepwise multiple linear regression analysis (P = 0.002, 0.011, and 0.009, respectively).
Conclusion Our results confirm the contribution of neutrophil activation in the development of DR. Neutrophil activation may be served as a new target for the treatment of DR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32532 0
Address 32532 0
Country 32532 0
Phone 32532 0
Fax 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)
Fax 15779 0
Email 15779 0
[email protected]
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)
Fax 6707 0
Email 6707 0
[email protected]

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