The objective of this clinical trial is evaluation of the effect Photorefractive Keratectomy on Hypermetropia using Wavelight Excimer Laser system.
Design
Randomised, open label clinical trial, phase 2 with a single group design of 20 patients with Hypermetropia.
Settings and conduct
All of these patients will operated PRK (photorefractive keratectomy) by Wavelight Excimer Laser system in Alavi hospital of Ardabil city. 30 minutes postoperative, 1 week, 1 month, 3 months, 6 months and one year postoperative results were compared with preoperative
data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hypermetropia patients up to 6.00 diopters and older than 18 years. Exclusion criteria: History of corneal surgery; herpetic eye disease; corneal dystrophy and scar; keratoconus; severe dry eye and collagen vascular disease.
Intervention groups
All of these patients will operated PRK (photorefractive keratectomy) by Wavelight Excimer Laser system.
Main outcome variables
Patients will be examined for The Hypermetropia clinical manifestations after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N9
Registration date:2018-04-11, 1397/01/22
Registration timing:prospective
Last update:2018-04-11, 1397/01/22
Update count:0
Registration date
2018-04-11, 1397/01/22
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of PhotorefractiveKeratectomy on Hypermetropia by Wavelight Excimer Laser system
Public title
Effect of Photorefractive Keratectomy on Hypermetropia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years; Hypermetropia up to 6.00 diopters
Exclusion criteria:
History of corneal surgery; herpetic eye disease; corneal dystrophy and scar; keratoconus; severe dry eye and collagen vascular disease.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Ardebil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil , Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.ARUMS.REC.1396.147
Health conditions studied
1
Description of health condition studied
Hyperopia
ICD-10 code
H52.0
ICD-10 code description
Hypermetropia
Primary outcomes
1
Description
The Hypermetropia clinical manifestations
Timepoint
30 minutes postoperative, 1 week, 1 month, 3 months, 6 months and one year postoperative
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Photorefractive keratectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Vice Chancellor for research of Ardebil University of Medical Sciences
Full name of responsible person
Dr Habib Ojaghi
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Habib Ojaghi
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Rahim Masomi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil , Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Habib Ojaghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Behrad Shahin
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data after unidentifiable individuals
When the data will become available and for how long
Start the access period from 2021
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Behrad Shahin; Medical student; Naghizadeh73@yahoo.com
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week.