Regarding high prevalence of cataract surgery and posterior capsular opacity as its complication that need laser capsulotomy, and at the other hand rising intra ocular pressure after laser capsulotomy, this clinical trial study was done on 200 eyes of patients after YAG laser capsulotomy for posterior capsular opacity to evaluate and compare the effect of apraclonidine and timolol separately in decreasing intraocular pressure after laser capsulotomy in Matini hospital, Kashan.
Inclusion criteria was posterior capsular opacity after uncomplicated cataract surgery according to clinical symptoms and ophthalmologist slit lamp examination.
Exclusion criteria were glaucoma and anterior segment diseases.
First intraocular pressure was checked with Goldman applanation tonometery method, then the patients were divided randomly into two groups and each group was treated with timolol 0.5% eye drop(Sinadaroo made) or apraclonidine 0.5% eye drop (Alcon made) double blindly. Yag laser capsulotomy performed for patients 1 hour thereafter. Again intraocular pressure was recorded 6 and 24 hours after capsulotomy with the same method. Data entered SPSS software version 15 and were analyzed with Chi-Square, T-test, Reapeted mesaurement and bonferroni tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109267218N2
Registration date:2011-10-07, 1390/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-07, 1390/07/15
Registrant information
Name
hasan farajipoor
Name of organization / entity
kashan universiyt of medical sceince
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 2020
Email address
farajipoor_h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between apraclonidine and timolol in preventing itraocular pressure rise after YAG laser capsulotomy
Public title
comparison between apraclonidine and timolol in preventing itraocular pressure rise after YAG laser capsulotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with posterior capsular opacity after uncomplicated cataract surgery
Exclusion criteria: glaucoma, anterior segment diseses
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
kashan university of medical science
Street address
ghotb ravandi blvd kiloometer 5
City
kashan
Postal code
8715988141
Approval date
2009-06-16, 1388/03/26
Ethics committee reference number
p/29/511/800
Health conditions studied
1
Description of health condition studied
posterior capsular opacity
ICD-10 code
H26.4
ICD-10 code description
After-cataract
Primary outcomes
1
Description
itraocular pressure
Timepoint
1 hour before and 6 and 24 hour after laser
Method of measurement
goldman tonometry
Secondary outcomes
1
Description
no intraocular pressure rise
Timepoint
no intraocular pressure rise
Method of measurement
no intraocular pressure rise
Intervention groups
1
Description
Group1: Timolol eye drop 0.5% ( Sina daroo made) applied 1 hour before laser, then after 6 and 24 hour laser intraocular pressure cheked.
Category
Treatment - Drugs
2
Description
Group2: Apraclonidine eye drop 0.5% ( Alcon made) applied 1 hour before laser, then after 6 and 24 hour laser intraocular pressure cheked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
kashan matini hospital
Full name of responsible person
Dr hasan farajipoor
Street address
Esfahan state, kashan city, Amirkabir Ave, Matini hospital
City
kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kashan university of medical science
Full name of responsible person
Dr gholamali hamidi
Street address
ghotb ravandi blvd kiloometer 5, kashan university of medical science
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kashan 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
matini hospital
Full name of responsible person
Dr hasan farajipoor
Position
ophthalmologist
Other areas of specialty/work
Street address
amirkabir ave
City
kashan
Postal code
8719674591
Phone
+98 36 1534 2020
Fax
+98 36 1534 2025
Email
Farajipoor_h@kaums.ac.ir h_farajypour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kashan university of medical science
Full name of responsible person
Dr hasan farajipoor
Position
ophthalmologist
Other areas of specialty/work
Street address
amirkabir ave, matini hospital
City
kashan
Postal code
8719674591
Phone
+98 36 1534 2020
Fax
+98 36 1534 2025
Email
Farajipoor_h@kaums.ac.irh_farajypour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
matini hospital
Full name of responsible person
Dr hasan farajipoor
Position
ophthalmologist
Other areas of specialty/work
Street address
amirkabir ave, matini hospital
City
kashan
Postal code
8719674591
Phone
+98 36 1534 2020
Fax
+98 36 1534 2025
Email
farajipoor_h@kaums.ac.ir
h_farajypour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)