Protocol summary

Summary
Pseudoexfoliative glaucoma is the most common secondary open-angle glaucoma. Forty patients with Pseudoexfoliative glaucoma who did not reach the target intraocular pressure with maximum tolerable antiglaucoma medications will be enrolled in this nonrandomized prospective intervention study. Exclusion criteria are congenital glaucoma, previous glaucoma surgery . Main outcome measures intraocular pressure (IOP) and the number of antiglaucoma medications used before surgery and after surgery at 2 hours, day 1, 1, 2, 3, 4, 5 and 6 months after selective laser trabeculoplasty (SLT). All the surgeries will be performed by 1 surgeon and before commencing surgery, 1 drop of Tetracaine (0.5%) will be instilled in each eye. Postoperative medications after SLT included Betamethasone twice a day for 3 days. At each visit, antiglaucoma medications and IOP will be measured and All major and minor complications will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021620619N3
Registration date: 2015-09-28, 1394/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-28, 1394/07/06
Registrant information
Name
Behzad Fallahi Motlagh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 1332
Email address
fallahib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-16, 1393/09/25
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of selective laser trabeculoplasty on intraocular pressure reduction in pseudoexfoliative glaucoma
Public title
Effect of selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) reduction in pseudoexfoliative glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with pseudoexfoliative glaucoma with uncontrolled pressure who need at least 20% decrease of IOP. Exclusion criteria: Previous SLT or intraocular surgery; angle closure glaucoma in which trabecular meshwork is not visible; IOP more 30 mmHg; any intraocular disease; congenital glaucoma.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
5165665931
Approval date
2014-12-14, 1393/09/23
Ethics committee reference number
93135

2

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
5165665931
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93135

Health conditions studied

1

Description of health condition studied
Pseudoexfoliative glaucoma
ICD-10 code
H40.5
ICD-10 code description
Pseudoexfoliative glaucoma

Primary outcomes

1

Description
Measured intra ocular presure after SLT in patients with pseudoexfoliative glaucoma
Timepoint
2 hours, 1 day, 1, 2, 3, 4, 5،6 and12 months after SLT
Method of measurement
Calibrated Goldman tonometer

Secondary outcomes

1

Description
Number of antiglaucoma medications
Timepoint
Baseline to 1, 2, 3, 4, 5,6 and 12 months
Method of measurement
Number of antiglaucoma medications

Intervention groups

1

Description
360 degree Selective laser trabeculoplasty with frequecy double Neodynium YAG
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Nikookari Eye Hospital
Full name of responsible person
Dr.Hakimallah Ghalamara
Street address
Tabriz .Abbasi street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nikookari Eye Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Dr Behzad Fallahi Motlagh,
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nikookari Eye Hospital, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
dr Hakimallah Ghalamara
Position
Resident in Ophthalmology,
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
+98 33359680
Email
afghalamara@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical SciencesDepartment of Ophthalmology,
Full name of responsible person
Dr. Behzad Fallahi Motlagh
Position
Associate Professor of Ophthalmology,
Other areas of specialty/work
Street address
Tabriz Nikookari Eye Hospital
City
Tabriz
Postal code
5154645395
Phone
+98 41 3335 5921
Fax
Email
bfm1346@yahoo.com
Web page address
www.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences,
Full name of responsible person
Dr.Hakimallah Ghalamara,
Position
Resident in Ophthalmology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
afghalamara@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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