Comparison of trabeculectomy with absorbable scleral flap sutures with releasable sutures in glaucoma patients
Design
Study is a clinical trial with control group , parallel groups 20 patient without blinding, randomization based on the 4-way random permutations method.
Settings and conduct
In Imam Khomeini Hospital of Ahvaz, trabeculectomy is performed in 40 patients in two groups without blinding.
In the control group nylon releasable sutures and in the case group two absorbable sutures for scleral flap are used.
The results and complications of surgery are compared in postoperative examination.
Participants/Inclusion and exclusion criteria
Inclusion criteriae: glaucoma patients referred to the ophthalmology center of Imam Khomeini Hospital in Ahwaz
with indication of trabeculectomy for intraocular pressure control
In these patients, intraocular pressure does not reach the target level with medication
Exclusion crateriae: history of any intraocular surgery except cataract surgery
history of extensive conjunctival injury
use of antimetabolite or corticosteroid drugs
History of collagenvascular disease
History of uveitis, endophthalmitis or any ocular inflammation
History of secondary glaucoma, congenital or neovascular glaucoma
Black patients
Patients with thin sclera
Intervention groups
In the case of trabeculectomy, the case group uses two polyglactin (Vicryl) 10.0 absorbable yarn sutures instead of non-absorbable sutures that will be completely covered with tenons and then conjunctiva. In the control group, trabeculectomy is performed with two releasable and nonabsorbable sutures.
Main outcome variables
post operative intraocular pressure, Visual Acuity, Ocular ant chamber depth, Other complications of trabeculectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190909044735N1
Registration date:2020-09-20, 1399/06/30
Registration timing:registered_while_recruiting
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Maliheh Darvishi Dastgerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3223 2899
Email address
maliheh.darvishi.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of trabeculectomy with absorbable scleral flap sutures with trabeculectomy with releasable sutures in glaucoma patients
Public title
Trabeculectomy surgery study with Vicryl scleral flap sutures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
glaucoma patients referred to the ophthalmology center of Imam Khomeini Hospital in Ahwaz
with indication of trabeculectomy for intraocular pressure control
In these patients, intraocular pressure does not reach the target level with medication
Exclusion criteria:
history of any intraocular surgery except cataract surgery
history of extensive conjunctival injury
use of antimetabolite or corticosteroid drugs
History of collagenvascular disease
History of uveitis, endophthalmitis or any ocular inflammation
History of secondary glaucoma, congenital or neovascular glaucoma
Black patients
Patients with thin sclera
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Possibility of two-eye surgery from one person
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly divided into two groups according to the four-way random permutations method. For example, if our blocks are 4, we have 6 blocks of AABB, ABAB, ABBA, BAAB, BAAB, BBAA, where we have to select n by dividing the 4 th sample by placement and thus obtain a randomization sequence. Randomization was achieved using WWW.sealedenvelope.com.
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 of Ahvaz Jundishapur University of Medical Sciences Research
Street address
No.4, Ground Floor, Vice Chancellor for Research and Technology Development, Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.AJUMS.REC.1398.413
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
post operative intraocular pressure
Timepoint
Intraocular pressure levels before surgery, morning after surgery, 3 days, one week, 2 weeks, 6 weeks and 3 months after surgery,
Method of measurement
The intraocular pressure will be measured by Goldman applan tonometer
Secondary outcomes
1
Description
Visual Acuity
Timepoint
postop day 7, 14 and 21
Method of measurement
Snellen
2
Description
Ocular ant chamber depth
Timepoint
postop day 1
Method of measurement
with slit lamp examination
3
Description
Other possible complications of trabeculectomy
Timepoint
Morning after surgery, 3 days, one week, 2 , 6 weeks and 3 months after surgery.
Method of measurement
in postop examination with slitlamp
Intervention groups
1
Description
Intervention group: In trabeculectomy surgery scleral flap should be fixed with two sutures. In this group we use absorbable sutures from Vicryl that does not require postoperative suture removal.
Category
Treatment - Surgery
2
Description
Control group: Scleral flap sutures are as usual made from nylon, this sutures are releasable and should be removed in postoperative examinations.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Fereydoon Farhi
Street address
Ophthalmology Department, Imam Khomeini Hospital, 24 meter street.
City
Ahwaz
Province
Khouzestan
Postal code
6193743954
Phone
+98 61 3223 2899
Email
maliheh.darvishi.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr mohammad badavi
Street address
Imam Khomeini Hospital, 24 meter street
City
Ahwaz
Province
Khouzestan
Postal code
6193743954
Phone
+98 61 3223 3899
Email
maliheh.darvishi.md@gmail.com
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
Fereidoon Farahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Ophthalmology Department, Imam Khomeini hospital, 24 meter street,
City
Ahvaz
Province
Khouzestan
Postal code
616193743954
Phone
+98 916 111 1328
Email
farahi-f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereidoon Farahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Ophthalmology Department, Imam Khomeini Hospital, 24 meter street.
City
Ahwaz
Province
Khouzestan
Postal code
616193743954
Phone
+98 916 111 1328
Email
farahi-f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereidoon Farahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Ophthalmology Department, Imam Khomeini Hospital, 24 meter street.
City
Ahvaz
Province
Khouzestan
Postal code
616193743954
Phone
+98 916 111 1328
Email
farahi-f@ajums.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
Yes - There is 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
Results of clinical examination after trabeculectomy in both case and control groups included intraocular pressure, visual acuity, anterior chamber depth changes, and any benefits or complications of trabeculectomy.
When the data will become available and for how long
After the publication of the paper resulting from this research
To whom data/document is available
Scholars who have access to the published article
Under which criteria data/document could be used
Copyright
From where data/document is obtainable
To the database of the journal in which the article is published
What processes are involved for a request to access data/document
Refer to the journal's website and access the article according to the journal's terms