Evaluation of the effect of using absorbable sutures in encircling band in reducing complications of scleral buckling surgery to treat pseudophakic retinal detachment
Use of releasable sutures in encircling band to treat pseudophakic retinal detachment
Design
Clinical trial without control group, with one intervention group, without blinding, without randomization, without drug intervention on 50 patients.
Settings and conduct
In this study, 50 patients with pseudophakic retinal detachment referred to the ophthalmology clinic of Imam Khomeini Hospital in Ahwaz will be evaluated by medical history and demographic information using a questionnaire and will be included in the study if they meet the inclusion criteria. Subsequently, patients will undergo scleral buckling surgery using vicryl absorbable suture in the encircling band and will be monitored and recorded ocular changes in terms of desired parameters one week, 3 months and 6 months after surgery.
Participants/Inclusion and exclusion criteria
Patients with pseudophakic retinal detachment referred to the ophthalmology clinic of Imam Khomeini Hospital in Ahwaz are included in the study.
Exclusion criteria: Previous history of retinal detachment surgery, diabetic retinopathy, glaucoma, uveitis, macular hole, age-related exudative macular degeneration, macular geographic atrophy, choroidal neovascular membrane and macular scar.
Intervention groups
Intervention group: 50 patients with pseudophakic retinal detachment and eligible for inclusion in the study will undergo scleral buckling surgery using absorbable suture vicryl 6-0 in the encircling band and then one week, three months and 6 months after surgery Follow-up of the observed variables will be used to evaluate the effect of the technique used in reducing the complications of surgery.
Main outcome variables
Determination of visual acuity; Refractive error; Eye axis length; Depth of anterior chamber
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200131046318N1
Registration date:2020-12-22, 1399/10/02
Registration timing:registered_while_recruiting
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
mahsa asadi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2818
Email address
mahsaasadimoghadam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using absorbable sutures in encircling band in reducing complications of scleral buckling surgery to treat pseudophakic retinal detachment
Public title
Use of absorbable suture in encircling band to treat pseudophakic retinal detachment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pseudophakic retinal detachment referred to the ophthalmology clinic of Imam Khomeini Hospital in Ahwaz
Exclusion criteria:
Previous history of retinal detachment surgery
History of diabetic retinopathy
History of glaucoma
History of uveitis
History of macular hole
History of age-related exudative macular degeneration
History of macular geographic atrophy
History of choroidal neovascular membrane
History of macular scar
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.AJUMS.REC.1397.490
Health conditions studied
1
Description of health condition studied
Pseudophakic retinal detachment
ICD-10 code
H33.8
ICD-10 code description
Other retinal detachments
Primary outcomes
1
Description
Visual acuity
Timepoint
Before surgery and one week, 3 months and 6 months after surgery
Method of measurement
A person's visual acuity according to Snellen chart at a distance of 6 meters
2
Description
Refractive error
Timepoint
Before surgery and one week, 3 months and 6 months after surgery
Method of measurement
Digital refractometer
3
Description
Eye axis length
Timepoint
Before surgery and one week, 3 months and 6 months after surgery
Method of measurement
IOL Master
4
Description
Depth of anterior chamber
Timepoint
Before surgery and one week, 3 months and 6 months after surgery
Method of measurement
IOL Master
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with pseudophakic retinal detachment will undergo scleral buckling surgery using absorbable suture yarn Vikril 0-6, domestically produced from Supa company , instead of non-absorbable 5-0 Merceline suture , in encircling band tightening suture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmology Clinic of Imam Khomeini Hospital in Ahwaz
Full name of responsible person
Mahsa Asadi Moghadam
Street address
Azadegan
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 4171
Email
mahsaasadimoghadam@gmail.com
Web page address
https://ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2828
Email
ajums@domain.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fereydoon Farhi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Azadegan, Imam Khomeini Hospital
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 4171
Email
ffarahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereydoon Farhi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Azadegan, Imam Khomeini Hospital
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 4171
Email
ffarahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Asadi Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Azadegan, Imam Khomeini Hospital
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 4171
Email
mahsaasadimoghadam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
No - There is not 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
Only part of the data such as information about the main outcome or the like can 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
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analysis is allowed on the shared data
From where data/document is obtainable
mahsaasadimoghadam@gmail.com
What processes are involved for a request to access data/document