a comparative study of fibrin glue versus suturing on higher order aberration in patients undergoing pterygium excision and free conjunctival autograft
Determination of the effect of pterygium surgery on high order aberrations using fibrin glue and suture
Design
two arm parallel groups non randomised trial with non blinded outcome assesment
Settings and conduct
patients suffering from pterygium devided into two groups and will undergo surgery one with fibrin glue and the other with suture method and 6 months after that , high order aberratins will be measured by pantacam and results will be compared by the results of presurgery high order aberrations in both groups
Participants/Inclusion and exclusion criteria
All patients with pterygium with surgical indication; history of anterior segment surgery, recent ophthalmic trauma, active intraocular inflammation, history of previous pterygium, contact lens use, chronic use of eye drops, corneal disease, dry eye
Intervention groups
patients in two groups,one by fibrin glue and the other by suture method will undergo surgery and both will be compared on high order aberations after surgery
a comparative study of fibrin glue versus suturing on higher order aberration in patients undergoing pterygium excision and free conjunctival autograft
Public title
study of high order aberrations in pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with pterygium that have surgical indication
Exclusion criteria:
History of pterygium surgery
History of Anterior Segment Surgery
Chronic use of eye drops
Corneal Diseases
using contact lens
Active intraocular inflammation
Recent Ophthalmic Trauma
dry eye
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee in Research, Tabriz University of Medical Sciences
Street address
No.8 , 2th alley , new lida , valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157844333
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.TBZMED.REC.1399.043
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
high order aberrations
Timepoint
The beginning of the intervention and 6 months after the surgery
Method of measurement
pentacam device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by 10-0 nylon suture.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks.aberrometry of patients will be measured before and 6 months after surgery by pantacam.
Category
Treatment - Surgery
2
Description
Intervention group 2:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by fibrin glue.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks..aberrometry of patients will be measured before and 6 months after surgery by pantacam.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari hospital
Full name of responsible person
nazli taheri
Street address
No.8 , 2nd alley., new lida street.,valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157834333
Phone
+98 41 3331 3959
Email
timman.med1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ata mahmoodpoor
Street address
No. 8 , 2nd alley., new lida stret., valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157844333
Phone
+98 41 3331 3959
Email
timmam.med1994@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
aminreza deljooy
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 8 , 2nd alley.,lida street.,valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157844333
Phone
+98 41 3331 3959
Email
timman.med1994@gmal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
aminreza deljooy
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 8 , 2nd alley.,lida street.,valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157844333
Phone
+98 41 3331 3959
Email
timman.med1994@gmal.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
aminreza deljooy
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 8 , 2nd alley.,lida street.,valiasr town
City
tabriz
Province
East Azarbaijan
Postal code
5157844333
Phone
+98 41 3331 3959
Email
timman.med1994@gmal.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
All data is shared after the identities of the study subjects are unrecognizable
When the data will become available and for how long
Accessing datas 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
The relevance of the applicant's field to the study , for example, being a physician, having a justified reason for accessing the data of individuals, accessing the data only for the purpose of obtaining further information on the study, the individual's commitment not to Misuse of people's data
From where data/document is obtainable
nikookari hospital , cornea clinic , dr nazli taheri
nikookari hospital , office of research assistance
What processes are involved for a request to access data/document
Authentication of the data requesting person, having a scientific and justifiable reason for accessing the data and presenting it to the hospital research assistant, specifying the amount of data access, confirming the research assistant, referring to the person in charge of the research, Dr. Nazli Taheri, Approved by Dr. Taheri