comparison between retinal injury and success in treatment of macular hole closure with two different method for ILM peeling ( pinch versus scraper)
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
All patients with stage 2 and more of macular hole that candidated for surgery and went to khatamanbia hospitalare choosed and then in randomised method are splitted i interventional and control group
in control group same surgical method for macular hole surgery for ILM peeling used pinch instrument and interventional group for ILM removal we used diamond dusted membrane scraper.another surgical method were the same in both group .these two instrument were same macroscopic morrphologic appearance. patient ,researcher , analayzer did not have any information about type of group
Participants/Inclusion and exclusion criteria
inclusion criteria : All patients with macular hole stage 2 and more that candidated for surgical treatment of macular hole closure.
exclusion criteria : Diabetic retinopathy ,AMD,retinal occluded vessel disease, mayopic patient , history of ocular inflamatory disease . trauma , lamelar macular hole , chronic macular hole ( more than 12 month),prevoius ILM peeling surgury , prevoius vitrectomy.
Intervention groups
Intervetional group we used diamon dusted membarne scraper with same macroscopic morphologic appearnce .
Control group ,we used pinch for ILM removal
at the same time i both group had viterctomy and gas injection .(with the same surgical method)
Main outcome variables
the rate of successsion for macluar hole closure
General information
Reason for update
Acronym
scraper in macular hole surgery
IRCT registration information
IRCT registration number:IRCT20180406039202N1
Registration date:2019-04-16, 1398/01/27
Registration timing:retrospective
Last update:2019-04-16, 1398/01/27
Update count:0
Registration date
2019-04-16, 1398/01/27
Registrant information
Name
yalda jannesar boroujerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 0933
Email address
jannesary941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
2018-02-12, 1396/11/23
Actual recruitment end date
2019-01-29, 1397/11/09
Trial completion date
2019-01-29, 1397/11/09
Scientific title
comparison between retinal ingery and success in treatment of macular hole surgery(pinch versus scraper)
Public title
comparison between retinal ingery and success in treatment of macular hole surgery(pinch versus scraper)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
any patient with stage 2 and more of macular hole that candidatet for surgery.
Exclusion criteria:
Diabetic retinopathy
AMD
Retinal occulded vessel
Myopic patients,
History of ocular inflamatory disease
trauma
Lamelar macular hole
Chronic macular hole (more than 12 months)
Previous ILM peeling
Previous vitrectomy
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization,individual,pinch( control group ) versus scraper (intreventional group)instrument.patient,researcher and analyser did not have any information about type of groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
we used pinch instrument in control group hower we used scraper in interventional group(its appearance is looks like pinch .but it had diamond-dusted membrane scraper and under surgical microscope .it could be difference) for ILM peeling .patients.researcher, analayzer.did not have any information about type of group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad university of medical scienses
Street address
Mashad university of medical sciense, azadi ave,mashad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MUMS.fm.REC.1396.646
Health conditions studied
1
Description of health condition studied
Macular hole
ICD-10 code
H35.89
ICD-10 code description
Other specified retinal disorders
Primary outcomes
1
Description
anatomic success of macular hole closure
Timepoint
in comparison between retinal ingery and anaomic success in macular hole closure in 2 different method of ILM peeling with pinch versus scraper, the anatomic success checked 3 months after surgery with OCT
Method of measurement
in comparison between retinal ingery and anaomic success in macular hole closure in 2 different method of ILM peeling with pinch versus scraper, the anatomic success checked 3 months after surgery with OCT(optical coherense tomography)
Secondary outcomes
1
Description
Visiual acquity
Timepoint
before and 3 months after surgery
Method of measurement
Visiual acqiuty measurment by snellen chart
2
Description
Macular thickness and density
Timepoint
before and 3 months after surgery
Method of measurement
OCT-A instrument
3
Description
RNFL thickness
Timepoint
before and 3 months after surgery
Method of measurement
RNFL-OCT instrument
Intervention groups
1
Description
Intervention group: use Diamond -dusted membrane scraper for ILM peeling with vitrectomy and gas injection
Category
Treatment - Surgery
2
Description
Control group: In this group we used the same surgical Macular hole procedure technique for ILM peeeling .at the same time we used vitrectomy and Gas injection
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamanbia hospital in mashhad
Full name of responsible person
Shoeybi Naser
Street address
Khatamambia hospital, abootaleb ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Email
Shoeybin@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
ghoreyshi building, daneshgah ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3845 2474
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shoeybi Naser
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khatam alanbia hospital, abootaeb blvd, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Email
Shoeybin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shoeybi Naser
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khatamanbia hospital, abootaleb blvd, mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Email
Shoeybin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shoeybi Naser
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khatamanbia hospital, abootaleb ave, Mahhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Email
Shoeybin@mums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
any detail going to published
When the data will become available and for how long
6 months after validity
To whom data/document is available
Any scientific and collegiate institutions
Under which criteria data/document could be used
Any analusis allowed
From where data/document is obtainable
Yaldajannesar@gmail.com
What processes are involved for a request to access data/document