Comparison of the astigmatism axis before and after cycloplegic refraction
Design
In this study 50 patients with astigmatism referring Zahedan Al-Zahra eye hospital will be included in study.
Settings and conduct
In this study 50 patients with astigmatism referring Zahedan Al-Zahra eye hospital will be included in study. All the patients will be assessed by an ophthalmologist by means of a autorefractor and retinoscopy and astigmatism dioptric power and astigmatism axis angle will be determined. Then, cyclopentoat 0/5 % drop ( 3 drops in each eye with a 5 minutes interval) and phenylephrine 10 %will be used; we will wait 30 minutes for a complete midriasis. The patients' eyes will be assessed again by the same ophthalmologist and the same sets. Finally, the data will be compared before and after using drops.
Participants/Inclusion and exclusion criteria
Inclusion criterion: all the patients with astigmatism referring Al-Zahra ophthalmology clinic in Zahedan
Exclusion criteria: previous eye trauma; previous corneal surgeries; corneal scar; corneal laceration; Down syndrome.
Intervention groups
All the patients will receive cyclopentoate 0/5 % and phenylephrine.
Main outcome variables
Astigmatism axis angle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171227038103N1
Registration date:2018-02-01, 1396/11/12
Registration timing:registered_while_recruiting
Last update:2018-02-01, 1396/11/12
Update count:0
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Nadiya Gheysaranpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
nadia.gheysaranpour@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the astigmatism axis angle before and after cycloplegic refraction in astigmatic patients
Public title
Investigation the changes in astigmatism axis before and after cycloplegic refraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referring ophthalmology clinic for evaluation and determining refractive error
Exclusion criteria:
Previous eye trauma
Previous corneal surgery
Corneal laceration
Down syndrome
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.ZAUMS.REC.1395.107
Health conditions studied
1
Description of health condition studied
Astigmatism
ICD-10 code
H52.2
ICD-10 code description
Astigmatism
Primary outcomes
1
Description
Astigmatism axis angle
Timepoint
Before and after intervention
Method of measurement
By using autorefractometre
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: cyclopentoat 0/5 % drop ( 3 drops in each eye with a 5 minutes interval) and phenylephrine 10 %
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra eye hospital
Full name of responsible person
Nadia Gheysaranpoor
Street address
Alzahra eye hospital, Motahhari Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Nadiya.gheisaran@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
hrafighdoost@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nadiya Gheysaranpoor
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Nadiya.gheisaran@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nadiya Gheysaranpoor
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
nadiya.gheisaran@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nadiya Gheysaranpoor
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
Nadiya.gheisaran@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available