Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001279213
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the blood profile of patients with pterygium ('surfers eye') compared with healthy volunteers
Scientific title
Complete blood count parameters of patients with pterygium compared with healthy volunteers.
Secondary ID [1] 295546 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pterygium 308813 0
Condition category
Condition code
Eye 307745 307745 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Detailed systemic and ophthalmic history of the participants were obtained and all subjects were underwent comprehensive ophthalmic examination. Complete blood count analysis was carried out for the pterygium patients and healthy control subjects. Blood analysis was carried out a week before the excision surgery for pterygium patients. Neutrophil, lymphocyte, monocyte and platelet counts, and mean platelet volume measurements was performed within 2 hours after collection of blood samples with an automatic analyzer. The neutrophil to lymphocyte ratio , monocyte to lymphocyte ratio and platelet to lymphocyte ratio were calculated by dividing the neutrophil count by lymphocyte count, monocytes count by lymphocyte count and platelet count by lymphocyte count respectively.The pterygium patients classified into 3 subgroups as atrophic, fleshy and intermediate according to Tan’s classification. All the obtained parameters were compared between the groups and among the subgroups statistically.
Intervention code [1] 301846 0
Early Detection / Screening
Comparator / control treatment
Healthy volunteers were used as a comparator (control) group. No treatment was performed for the control group and only blood samples were taken.
Control group
Active

Outcomes
Primary outcome [1] 306734 0
After the complete blood count analysis mean platelet volume (MPV) was evaluated in patients with pterygium and compared with healthy subjects.
Timepoint [1] 306734 0
Pre-operative (a week before the surgery) complete blood counts of pterygium patients and control subjects were obtained.
Primary outcome [2] 306898 0
After the complete blood count analysis, platelet to lymphocyte ratio (PLR) was evaluated in patients with pterygium and compared with healthy subjects.
Timepoint [2] 306898 0
Pre-operative (a week before the surgery) complete blood counts of pterygium patients and control subjects were obtained.
Secondary outcome [1] 349373 0
After the complete blood count analysis, neutrophil to lymphocyte ratio (NLR) was evaluated in patients with pterygium and compared with healthy subjects.
Timepoint [1] 349373 0
Pre-operative (a week before the surgery) complete blood counts of pterygium patients and control subjects were obtained.
Secondary outcome [2] 350049 0
After the complete blood count analysis, monocyte to lymphocyte ratio (MLR) was evaluated in patients with pterygium and compared with healthy subjects.
Timepoint [2] 350049 0
Pre-operative (a week before the surgery) complete blood counts of pterygium patients and control subjects were obtained.

Eligibility
Key inclusion criteria
individuals with pterygium
healthy individuals
volunteer
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with recurrent pterygium,
history of any other ocular disorder or surgery(such as corneal trauma, corneal scarring, glaucoma,uveitis or severe dry eye),
suffering from any systemic disorder,
systemic inflammation or clinical condition,
pregnancy.
atopy,
currently using any topical or systemic medication or anti-inflammatory/antioxidant therapies

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The normal distribution assumption was tested with Kolmogorov–Smirnov test. The statistical methods evaluating the data were the chi-square, independent t test and Spearman’s Rho correlation test. The overall accuracy was determined by the area under the curve, sensitivity and specificity using receiver-operating characteristic (ROC) analysis. In all tests, a p value <0.05 was considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/11/2015
Date of last participant enrolment
Anticipated
Actual
14/02/2016
Date of last data collection
Anticipated
Actual
16/03/2016
Sample size
Target
120
Accrual to date
Final
117
Recruitment outside Australia
Country [1] 10643 0
Turkey
State/province [1] 10643 0
Kirsehir

Funding & Sponsors
Funding source category [1] 300122 0
Hospital
Name [1] 300122 0
Ahi Evran University Training and Research Hospital
Country [1] 300122 0
Turkey
Primary sponsor type
Hospital
Name
Ahi Evran University Training and Research Hospital
Address
Kervansaray district, Kayseri-Ankara Street (2019.street), no:1, Kirsehir, 40200,Turkey.
Country
Turkey
Secondary sponsor category [1] 299523 0
None
Name [1] 299523 0
Address [1] 299523 0
Country [1] 299523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300962 0
Ahi Evran University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 300962 0
Ethics committee country [1] 300962 0
Turkey
Date submitted for ethics approval [1] 300962 0
12/10/2015
Approval date [1] 300962 0
03/11/2015
Ethics approval number [1] 300962 0
99950669/293

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85430 0
Dr Ali Kurt
Address 85430 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 85430 0
Turkey
Phone 85430 0
+90 537 0275488
Fax 85430 0
Email 85430 0
[email protected]
Contact person for public queries
Name 85431 0
Ali Kurt
Address 85431 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 85431 0
Turkey
Phone 85431 0
+90 537 0275488
Fax 85431 0
Email 85431 0
[email protected]
Contact person for scientific queries
Name 85432 0
Ali Kurt
Address 85432 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 85432 0
Turkey
Phone 85432 0
+90 537 0275488
Fax 85432 0
Email 85432 0
[email protected]

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.