Protocol summary

Summary
Glaucoma is one of the most important cause of blindness in the world .The most common cause of glaucoma is open angle glaucoma. Because medical treatment of glaucoma has a high rate of non-compliance due to chronicity of disease, laser treatment of open angle glaucoma is an option as a primary or adjuvant treatment. Selective laser trabeculoplasty introduced in 1997 and approved by FDA in 2001.In this laser by Q –Switch Frequency double ND: YAG pigmented TM cells stimulate in 3 nanosecond and IOP decrease without lateral disruption of TM .This laser is useful in primary open angle glaucoma, ocular hypertension, pigmentry, pseudoexfoliative and steroid induced glaucoma. Different studies have shown that mean IOP can decrease 4-6 mmHg in 6 month follow up. There are few studies in literature about comparison of 360 degree SLT in primary open angle and pseudoexfoliative glaucoma. In addition to decreasing IOP and number of anti-glaucoma medications this laser doesn’t interfere with surgery and can increase patient compliance and we decide to evaluate effect of 360 degree SLT in a prospective study on IOP of patients with 1-POAG 2-pseudoexfoliative glaucoma with uncontrolled pressure who need at least 20% decrease of IOP or the same patients with newly diagnosis of POAG or PXF glaucoma who need at least 20% decrease of IOP in Rasoul Akram hospital.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008124558N1
Registration date: 2010-10-10, 1389/07/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-10-10, 1389/07/18
Registrant information
Name
Arezou Miraftabi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 9380
Email address
a.miraftab@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare effect of selective laser trabeculoplasty on IOP in Primary open angle and pseudoexfoliative glaucoma
Public title
To compare effect of selective laser trabeculoplasty on IOP in Primary open angle and pseudoexfoliative glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with 1-POAG 2-pseudoexfoliative glaucoma with uncontrolled pressure who need at least 20% decrease of IOP or the same patients with newly diagnosed POAG or PXF glaucoma who need at least 20% decrease of IOP Exclusion criteria: previous ALT or intraocular surgery 2-Angle closure glaucoma in which TM is not visible 3-IOP>30 mmHg 4-Advanced visual field defect 6-central 10 degree involvement and split fixation 7-any intraocular disease
Age
To 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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
Eye research center, Rasoul Akram Hospital
Street address
Niayash street, Sattarkhan street, Rasoul Akram Hospital
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
478 م ت

Health conditions studied

1

Description of health condition studied
primary open angle and pseudoexfoliative glaucoma
ICD-10 code
H 40.1
ICD-10 code description
primary open angle glaucoma and PXF glaucoma

Primary outcomes

1

Description
Intraocular pressure
Timepoint
Control of IOP 2 hours, one day, one week, 3 months, 6 months after SLT and in the last follow up
Method of measurement
calibrated Goldman tonometer

Secondary outcomes

1

Description
complications of SLT
Timepoint
2 hours, one day, one week, 3 months, 6 months after SLT and in the last follow up
Method of measurement
complete SLit lamp exam and fundoscopy and gonioscopy

Intervention groups

1

Description
360 degree Selective laser trabeculoplasty with frequecy double Neodynium YAG
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr.Arezoo Miraftabi
Street address
Niayesh street, SatarKhan Street, Rasoul Akram Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Science
Full name of responsible person
Mrs Dehban
Street address
Hematt Highway ,Adjacent to Milad tower
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Dr.Arezoo Miraftabi
Position
Assistant professor
Other areas of specialty/work
Street address
Niayesh street-SatarKhan Street-Rasoul Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9162
Fax
Email
a.miraftab@iums.ac.ir; miraftaboo@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Arezoo Miraftabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hemmat highway, Adjacent to Milad Tower
City
Tehran
Postal code
Phone
+98 21 8805 2265
Fax
+98 21 6650 9162
Email
a.miraftab@iums.ac.ir; miraftaboo@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Arezoo Miraftabi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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