comparison of nylon sutures versus vicryl sutures on conjunctival autografting of pterygium surgery
Design
This is a randomized clinical trial .Sample selection was easy and accessible and sample size was considered as two groups of 35. Samples were patients with pterygium referred randomly to Shahid Sadoughi Hospital in Yazd.Randomly divided into two groups a: using nylon sutures and group b: using vicryl sutures for suturing the conjunctival autograft.
Settings and conduct
After obtaining the code of ethics and registration in the Clinical Trial Center (RCT), 70 eligible patients are included in the study. After a thorough examination by an ophthalmologist or ophthalmologist, they are divided into two groups of 35 A and B according to a random table. A: The use of nylon thread and group B: the use of vicryl thread. After collection, the data are entered into STATA14 software and according to the qualitative nature of most dependent variables will be analyzed using Chi-square test. Also, the pain score variable will be compared between the two groups using the non-parametric Mann-Whitney U test.
Participants/Inclusion and exclusion criteria
age more than 18
people with decreased vision or stigma more than 3D
Patients with complaints of apparent malformation of the pterygium
people with pseudo pterygium
people with collagen vascular sickness
people with Corneal dystrophy
people with sever dry eye
people with previous history of pterygium surgery
people with temporal pterygium
Intervention groups
GROUP A: using nylon sutures for conjunctival auotografting
GROUP B: using Vicryl sutures for conjunctival auotografting
Main outcome variables
Knot opening, foreign body sensation, redness of eyes, pain intensity, conjunctival camouflage, papillary reaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220513054834N1
Registration date:2022-06-29, 1401/04/08
Registration timing:retrospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
saeede akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 387 9500
Email address
saeede.light@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of nylon versus vicryl sutures on conjunctival autografting in pterygium surgery
Public title
comparison of nylon versus vicryl sutures on conjunctival autografting in pterygium surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 18
people with decreased vision or stigma more than 3D
Patients with complaints of apparent malformation of the pterygium
Exclusion criteria:
people with pseudo pterygium
people with collagen vascular sickness
people with Corneal dystrophy
people with sever dry eye
people with previous history of pterygium surgery
people with temporal pterygium
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with a block randomization list was
used to allocate patients to either vicryl or nylon suture
groups.Patients were unaware of the suture material
being used, but the surgeon and postoperative assessor
were not masked to the assignment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of yazd university of medical sciences
Street address
Yazd, Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
34245534
Approval date
2022-05-02, 1401/02/12
Ethics committee reference number
IR.SSU.SPH.REC.1401.010
Health conditions studied
1
Description of health condition studied
Pterygium
ICD-10 code
H11.0
ICD-10 code description
Pterygium of eye
Primary outcomes
1
Description
Untie the knot
Timepoint
Examination is performed on the 1st, 7th, 4th and 8th week after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant.
Method of measurement
visual analogue scale questionnaire
Secondary outcomes
1
Description
eye redness
Timepoint
Examination is performed on the 1st, 7th, 4th and 8th week after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant.
Method of measurement
As an observation
Intervention groups
1
Description
This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open.
Category
Treatment - Surgery
2
Description
This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Yazd hospital
Full name of responsible person
saeede akbari
Street address
Yazd, Shahid Ghandi Boulevard, Ibn Sina Boulevard
City
Yazd
Province
Yazd
Postal code
8785789158
Phone
+98 35 3822 4000
Email
saeede.light@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr mehrparvar
Street address
Yazd, Shahid Ghandi Boulevard, Ibn Sina Boulevard
City
Yazd
Province
Yazd
Postal code
4555644332
Phone
+98 35 3724 0171
Email
saeede.light@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
saeede akbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
surgical technologist
Street address
Beheshti Town - Soroush St. - Soroush 1/4
City
شهرصنعتی بزرگ /شیراز
Province
Fars
Postal code
718936345
Phone
0731 360 4726
Email
saeede.light@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Shoja
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
daneshjoo blv
City
Yazd
Province
Yazd
Postal code
2343545
Phone
0350898983
Email
saeede.light@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
saeede akbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
surgical technologist
Street address
Beheshti Town - Soroush St. - Soroush 1/4
City
شهرصنعتی بزرگ /شیراز
Province
Fars
Postal code
89639768776
Phone
07316404726
Email
saeede.light@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data contains the main consequences to be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It must be decided by the circumstances of the time
From where data/document is obtainable
Request the email of the project manager.
What processes are involved for a request to access data/document