The aim of this study to compare trabeculectomy with releasable sutures and standard trabeculectomy in treatment of glaucoma. Plan: A block-randomized, single-blind, placebo-controlled Clinical Trial, Phase II. Inclusion criteria: Primary open angle glaucoma, primary angle closure glaucoma who didn't respond to medication. Exclusion criteria: uveitis, post-traumatic, neovascular and Juvenile glaucoma. Previous ophthalmic surgery and combined procedures (glaucoma and cataract). Interventions: First group of patients will undergo a trabeculectomy with releasable sutures, and the second group will undergo a standard trabeculectomy. Primary outcome: Reduction in intraocular pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401148410N2
Registration date:2014-09-10, 1393/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-10, 1393/06/19
Registrant information
Name
Ahmad Sarvarian
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 5075
Email address
dr.ahsarvarian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
research adjutancy of the arak university of medical sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-11-30, 1391/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of trabeculectomy with releasable sutures and standard trabeculectomy in treatment of glaucoma
Public title
trabeculectomy with releasable sutures in treatment of glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Primary open angle glaucoma; primary angle closure glaucoma who didn't Respond to medication
exclusion criteria: uveitic; post-traumatic; neovascular; Juvenile glaucoma; Previous ophthalmic surgery; combined procedures (glaucoma and cataract)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the arak university of medical sciences
Street address
Arak University of Medical Sciences, Alamolhoda Ave
City
Arak
Postal code
Approval date
2012-01-30, 1390/11/10
Ethics committee reference number
90-119-4
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40.1
ICD-10 code description
Primary open-angle glaucoma
Primary outcomes
1
Description
intraocular pressure
Timepoint
before trabeculectomy and 24 hours after trabeculectomy
Method of measurement
Goldmann tonometry
Secondary outcomes
1
Description
shallow anterior chamber
Timepoint
24 hours after trabeculectomy
Method of measurement
measurement with slit lamp
2
Description
iridocorneal touch
Timepoint
24 hours after trabeculectomy
Method of measurement
observation with slit lamp
3
Description
corneal edema
Timepoint
24 hours after trabeculectomy
Method of measurement
observation with slit lamp
4
Description
Hyphema
Timepoint
24 hours after trabeculectomy
Method of measurement
observation with slit lamp
Intervention groups
1
Description
patients of first group undergo trabeculectomy with releasable sutures. 24 hour after surgery anterior chamber depth, intraocular pressure, hyphema and iridocorneal touch will evaluate.
Category
Treatment - Surgery
2
Description
patients of second group undergo standard trabeculectomy. 24 hour after surgery anterior chamber depth, intraocular pressure, hyphema and iridocorneal touch will evaluate.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Ahmad Sarvarian
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University Of Medical Sciences, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ahmad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ahmad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 3313 5075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ahmad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)