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
ACTRN12616000620426
Ethics application status
Approved
Date submitted
8/03/2016
Date registered
12/05/2016
Date last updated
21/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing success rates of two surgical techniques for involutional entropion of the lower eyelid: the everting sutures and the lateral tarsal strip.
Scientific title
Prospective randomised controlled trial to compare success rates of two surgical techniques for involutional entropion of the lower eyelid:the everting sutures and the lateral tarsal strip.
Secondary ID [1] 288615 0
none
Universal Trial Number (UTN)
U1111-1180-0298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Involutional entropion of the lower eyelid. 297766 0
Condition category
Condition code
Eye 297953 297953 0 0
Diseases / disorders of the eye
Surgery 298512 298512 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients suffering from primary involutional entropion will participate in the study. Patients will be randomised to everting sutures technique (commonly used) and to lateral tarsal strip technique (commonly not used as standard practice).
The lateral tarsal strip technique:
Cantholysis of the lateral palpebral ligament.
Preparation of an outer tarsus flap (sling) by removing the dermis, the orbicularis muscle and the conjuctiva.
Flap fixation by using sutures 5.0 to the temporal orbit periosteum .
Wound restorarion by using 6.0 sutures.
These procedures will be performed by the qualified ophthalmologist Elias Nakos expert in oculoplastics.
Intervention code [1] 294017 0
Treatment: Surgery
Comparator / control treatment
Control group: The everting sutures technique.
It consists in the insertion of three (3) absorbable sutures 6.0 with double needle obliquely from the lower limit of the palpebral conjuctiva through rhe skin of the eyelid below the eyelashes.
Control group
Active

Outcomes
Primary outcome [1] 297481 0
Success rate.
The success is assessed by clinical examination. At the follow-up visit, eyelid is asessed in the primary and downgaze position.
The patients will also asked to squeeze their eyelids closed to detect any latent recurrence.
The surgical success is defined as complete resolution of the inward eyelid margin rotation and symptoms.

Timepoint [1] 297481 0
6 (six) months and 1 (one) year follow up..
Primary outcome [2] 297482 0
Quality of life by using the VQF-25 Questionnaire preoperatively and at six months follow-up.
Timepoint [2] 297482 0
Preoperatively and at 6(six) months..
Secondary outcome [1] 321168 0
Complications rate by using clinical examination and asking the patient for possible problems postoperatively.
Timepoint [1] 321168 0
6 (six) months and 1 (one) year follow up.

Eligibility
Key inclusion criteria
Lower eyelid involutional entropion.
Minimum age
25 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Scarry entropion.
Another surgery for the same reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
About 40 to 60 patients is a satisfacory number of patients if we take under consideration the prevalence of the lower eyelid entropion in the general population.
Methods:
A.t-test : 1. independent samples t- test and
2. paired samples t-test.
In these two t tests, the null hypothesis being tested is that quantitative variable average values in both populations from which the planned "samples" are derived are equal. Thus, the p-value, the difference between the means of two "samples" and the 95% confidence interval for the difference, are calculated.
When the p-value is less than a value, which is usually defined at the level of 0.05, then the null hypothesis is rejected and the difference between the means of the two populations are statistically significant.
B. Non-parametric methods which take into account the provisions of observations rather than actual values of observations, making possible their application in the case of 'samples' with a small number of observations. In non-parametric methods, the null hypothesis is not the comparison of average populations prices from which they derive the "samples", but comparing medians.
Where the "samples" are two and independently the statistical test of Wilcoxon (wilcoxon rank-sum test devices) is used..
In the case where the "samples" are two, but in pairs, so for each observation in the first group there is a corresponding remark in the second group, the Wilcoxon signed-ranked test or sign test will be used.
C. If i need to make some correlation, the type and size of the linear relationship between two quantitative variables that follow the normal distribution is estimated by the correlation coefficient of Pearson (Pearson's coefficient of correlation), while when one of the two quantitative variables does not follow the normal distribution, then the correlation coefficient of Spearman provisions is used (Spearman's rank correlation coefficient).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7615 0
Greece
State/province [1] 7615 0

Funding & Sponsors
Funding source category [1] 292979 0
University
Name [1] 292979 0
Aristotle university medical school
Address [1] 292979 0
University city of Thessaloniki, Thessaloniki, Agiou Dimitriou st, 54124.
Country [1] 292979 0
Greece
Funding source category [2] 292980 0
Hospital
Name [2] 292980 0
AHEPA University General Hospital of Thessaloniki
Address [2] 292980 0
Kiriakidi 1, Thessaloniki, 54621.
Country [2] 292980 0
Greece
Funding source category [3] 292981 0
Hospital
Name [3] 292981 0
424 General Military Hospital of Thessaloniki
Address [3] 292981 0
Egnatia ring road of Thessaloniki, Thessaloniki, 56429.
Country [3] 292981 0
Greece
Primary sponsor type
University
Name
Aristotle university medical school, lab of experimental ophthalmology
Address
University city of Thessaloniki, Thessaloniki, Agiou Dimitriou st, 54124.
Country
Greece
Secondary sponsor category [1] 291751 0
None
Name [1] 291751 0
NONE
Address [1] 291751 0
NONE
Country [1] 291751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294490 0
Bioethics commitee of Aristotle university medical school
Ethics committee address [1] 294490 0
University city of Thessaloniki, Thessaloniki, Agiou Dimitriou st, 54124.
Ethics committee country [1] 294490 0
Greece
Date submitted for ethics approval [1] 294490 0
20/07/2013
Approval date [1] 294490 0
08/10/2013
Ethics approval number [1] 294490 0

Summary
Brief summary
The surgical treatment of the involutional entropion of the lower eyelid by using two techniques:
1. the everting sutures and
2. the lateral tarsal strip technique.
Prospective randomized comparative study of these two techniques.
I want to find which is the best procedure, the outcome of anatomical and functional recovery over time and their contribution to improving patients’ quality of life.
SURGICAL TECHNIQUES:
1. the everting sutures technique:
It consists in the insertion of three (3) absorbable sutures 6.0 with double needle obliquely from the lower limit of the palpebral conjunctiva through the skin of the eyelid below the eyelashes.
2. the lateral tarsal strip technique:
Cantholysis of the lateral palpebral ligament.
Preparation of an outer tarsus flap (sling) by removing the dermis, the orbicularis muscle and the conjuctiva.
Flap fixation by using sutures 5.0 to the temporal orbit periosteum .
Wound restorarion by using 6.0 sutures.
Based on the existing literature, there are some questions to be answered:
Which is the most appropriate surgical rehabilitation technique for the lower involutional eyelid entropion with the best success rates, fewer complications and the lower recurrence rates?
Importance:
The result of the investigation may lead to the predominance of one technique over the other and to establish criteria for their selection.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63846 0
Dr Nakos Elias
Address 63846 0
Eye Clinic, 424 General Military Hospital of Thessaloniki, Thessaloniki, ring road Egnatia, 56429
Country 63846 0
Greece
Phone 63846 0
+306949194259
Fax 63846 0
+302310638193
Email 63846 0
nakos342000@yahoo.gr
Contact person for public queries
Name 63847 0
Dr Nakos Elias
Address 63847 0
Eye Clinic, 424 General Military Hospital of Thessaloniki, Thessalonki, ring road Egnatia, 56429
Country 63847 0
Greece
Phone 63847 0
+306949194259
Fax 63847 0
+302310638193
Email 63847 0
nakos342000@yahoo.gr
Contact person for scientific queries
Name 63848 0
Dr Nakos Elias
Address 63848 0
Eye Clinic, 424 General Military Hospital of Thessaloniki, Thessaloniki, ring road Egnatia, 56429
Country 63848 0
Greece
Phone 63848 0
+306949194259
Fax 63848 0
+302310638193
Email 63848 0
nakos342000@yahoo.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary