1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effects of oral acetazolamide versus Cosopt drops to prevent increase in intraocular pressure after YAG laser in posterior capsulotomy

Protocol summary

Summary
Purpose: The purpose of this study is to compare therapeutic effects of oral acetazolamide versus Cosopt drops to prevent increase in intraocular pressure after Nd-YAG laser in posterior capsulotomy. Plan: A block-randomized, single-blind, placebo-controlled Clinical Trial, Phase II. Inclusion criteria: patients with age over 40 years who have undergone phacoemulsification surgery at least 3 months ago, and have posterior capsule opacity. Exclusion criteria: Patients with asthma and pulmonary obstructive diseases, medication side effects, retinopathy, severe corneal opacity, occurrence of intraoperative complications, history of glaucoma, uveitis, absence in the follow up, and traumatic cataract. Interventions: First group will receive oral acetazolamide with placebo drops, and the second group will receive Cosopt drops with oral placebo. Primary outcome: Reduction in intraocular pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112148410N1
Registration date: 2012-01-01, 1390/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-01, 1390/10/11
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
Arak University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of oral acetazolamide versus Cosopt drops to prevent increase in intraocular pressure after YAG laser in posterior capsulotomy
Public title
Comparison of the effects of oral acetazolamide versus Cosopt drops to prevent increase in intraocular pressure after YAG laser in posterior capsulotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. age over 40 years; 2. phacoemulsification surgery at least 3 months ago; 3. To have posterior capsule opacity; 4. patient should be operated by phacoemulsification method. Exclusion criteria: 1. asthma and pulmonary obstructive diseases; 2. medication side effects; 3. Retinopathy; 4. severe corneal opacity; 5. occurrence of intraoperative complications; 6. history of glaucoma; 7. Uveitis; 8. absence in the follow up; 9. traumatic cataract.
Age
From 40 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamolhoda Ave
City
Arak
Postal code
Approval date
2011-02-11, 1389/11/22
Ethics committee reference number
89-104-4

Health conditions studied

1

Description of health condition studied
Ocular hypertension
ICD-10 code
H40.0
ICD-10 code description
Glaucoma suspect: Ocular hypertension

Primary outcomes

1

Description
Ocular hypertension
Timepoint
before capsulotomy surgery and 24 hours after capsulotomy surgery
Method of measurement
Goldmann tonometry

Secondary outcomes

empty

Intervention groups

1

Description
First group, will receive oral acetazolamide 250 mg/6h and placebo drops every 8h after capsulotomy with laser for 24 hours.
Category
Treatment - Drugs

2

Description
Second group, will receive Cosopt drops every 8h and oral placebo capsule every 6h after capsulotomy with laser for 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Ahamd 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 Science, 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 Ahamad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 1313 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 Ahamad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 1313 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 Ahamad Sarvarian
Position
Ophthalmologist, Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Parastar Square
City
Arak
Postal code
Phone
+98 86 1313 5075
Fax
Email
dr.ahsarvarian@arakmu.ac.ir
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
Loading...