Protocol summary

Summary
In this clinical trial, two groups of patients with primary open angle glaucoma (intraocular pressure [IOP] between 21 and 30 mm Hg) are included. Each group contains 44 patients who are older than 16 years. Exclusion criteria include the use of topical and systemic carbonic anhydrase inhibitors and IOP > 30 mm Hg. One group will randomly receive 2% dorzolamide eye drops three times a day and the other group will randomly receive 0.005% latanoprost eye drops once a day. Examinations include manifest refraction using an auto-refractometer (average of three readings), best-spectacle corrected visual acuity with full-correcting glasses using Snellen chart, IOP measurements using Goldmann Applanation tonometer, slit lamp biomicroscopy of cornea and anterior chamber, non-dilated funduscopy, and automated perimetry (Humphrey perimetry). Central corneal thickness (CCT), anterior chamber depth (ACD), and lens thickness (LT) will be measured using IOLMaster. The measurements by IOLMaster as well as refraction will be repeated after the instillation of cyclopantolate eye drops. Two weeks after the initiation of anti-glaucoma medications, all above mentioned examinations will be repeated at least 2 hours after the use of drops. To evaluate the long-term effects, these measurements will be performed 6±1 weeks afterwards. The participants will have an access to the examiner whenever they have blurred vision. A statistical analysis will be used to compare the study groups in terms of any significant differences in refraction, CCT, ACD, and LT as well as to find any correlation between the use of each medication and blurred vision.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052813505N1
Registration date: 2014-09-07, 1393/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-07, 1393/06/16
Registrant information
Name
Hossein Mohammad-Rabie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982173430- 00982177558081
Email address
h_mohammadrabie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-06-21, 1392/03/31
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Long-term effect of topical Dorzolamide and Latanoprost on Refraction in patients with primary open-angle glaucoma
Public title
Effect of topical Dorzolamide and Latanoprost on Refraction
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: all patients with open angle glaucoma; older than 16; with eye pressure of 21 to 30 mm Hg which have not taken any treatment. Exclusion criteria: previous use of systemic or topical dorsolamide; using contact lens since 1 month ago; taking sulfa drug since 1 month ago; lactation; pregnancy (pregnancy reduce eye pressure and increase cornea thickness); cataract; any kind of eye surgery; CD/disc more than 0.8; best visually by less than 20/40 (with using Pin Hole); any neuropathy, any severe damage to visual field; and also any increase in eye pressure more than 30 mm Hg during the study.
Age
From 16 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Yaman alley, Velenjak av., Chamran subway
City
Tehran
Postal code
1985717443
Approval date
2013-05-19, 1392/02/29
Ethics committee reference number
sbmu.rec.1392.61

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
Refraction
Timepoint
2 and 6±1weeks
Method of measurement
Autorefractometr

Secondary outcomes

1

Description
Visual acuity, thickness of lens and cornea and depth of anterior chamber
Timepoint
2 and 6±1weeks
Method of measurement
Visual acuity with Snelen chart, thickness of lens and cornea and depth of anterior chamber by IOL Master

Intervention groups

1

Description
Control: Including patiens who will receive 0.005% latanoprost eye drops once a day for 6±1 weeks.
Category
Treatment - Drugs

2

Description
Control: including patients who will receive 2% dorzolamide eye drops three times a day for 6±1 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Basir Eye Center
Full name of responsible person
DR Mohammad-Rabie
Street address
Jamalzadeh Shomalli ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR Mohammad-Rabie
Street address
Yaman alley. Velenjak ave. Chamran subway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Moslehi Moghaddam
Position
MSc of Optometry
Other areas of specialty/work
Street address
N;124, Gholbarg st., Avval square of Tehranpars
City
Tehran
Postal code
1651734811
Phone
+98 21 7729 9258
Fax
Email
nana.opt@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR Mohammad-Rabie
Position
ّّAssociated professor of ophtalmology
Other areas of specialty/work
Street address
ٰٰTorfe Hospital,Baharestan Squ.
City
Tehran
Postal code
Phone
+98 21 7753 4171
Fax
Email
mhrabie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Moslehi Moghaddam
Position
MSc of Optometery
Other areas of specialty/work
Street address
N;124, Gholbarg st., Avval square of Tehranpars
City
Tehran
Postal code
1651734811
Phone
+98 21 7729 9258
Fax
Email
nana.opt@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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