To determine efficacy and safety of trans-epithelial photorefractive keratectomy (TPRK) compared to conventional PRK for treatment of astigmatism.
Design
Parallel, randomized double blind clinical trial, with contralateral control group.
Settings and conduct
Feiz Hospital and Parsian Eye Clinic, Isfahan, Iran. The subjects, outcome assessor, and data analyzer will be blinded with regard to grouping.
Participants/Inclusion and exclusion criteria
Inclusion:
-over 18 years old
-spherical error equal to or greater than -1 diopter and cylinder equal to or greater than 3 diopters in both eyes with minus cylinder notation
-Stable refraction during the last year
-No history of wearing contact lens for at least 3 weeks
-No history of Keratoconus and any type of corneal ectasia in the patient or his first-degree relatives.
Exclusion:
-Previous ocular surgery
-Active eye disease
-History of severe eye trauma
-Systemic diseases that potentially impair wound healing
-Taking inhaled or systemic steroids currently or in the last 3 months
Intervention groups
One eye, in each subject will randomly be assigned to the TPRK group, and the other eye will be treated with conventional PRK.
Efficacy and Safety of Trans Epithelial Compared to Conventional Photorefractive Keratectomy for Treatment of Astigmatism of more than 3 Diopters.
Public title
Trans Epithelial PRK for Treatment of High Astigmatic Error
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Stable refraction during the last year
No history of wearing contact lens for at least 3 weeks before the examination
No history of Keratoconus and any type of corneal ectasia in the patient or his first-degree family
sphere equal to or greater than -1 diopter and cylinder equal to or greater than 3 diopters in both eyes
Satisfaction and full knowledge of patients to enter the plan
Exclusion criteria:
Previous ocular surgery
Active eye disease, corneal dystrophy, retinal diseases, glaucoma, dry eye of any degree
History of severe eye trauma
Systemic diseases that potentially impair wound healing, including diabetes, collagen vascular disease, and pregnancy.
Taking inhaled or systemic steroids actively or for 3 months before the procedure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient, both eyes are operated on
Randomization (investigator's opinion)
Randomized
Randomization description
In a contralateral design, one eye of each subject will be assigned randomly to the study group, and the other eye of the same patient be assigned to the control group, by Random Allocation Software.
Random allocation table created by “Random Allocation Software” version 1.0.0 (developed by M. Saghaei, MD, Isfahan University of Medical Sciences). The number of groups set at 2 (namely OD, and OS), sample size: 40, on only one block, to find which eye of the sequential case numbers will be assigned to the intervention group.
The excimer device operator will have the random table; at the time of surgery, one eye will be assigned to the intervention group, and the contralateral eye to the control group, according to the allocation table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects know eyes will be operated with two techniques, they will not know which eye is operated by which way. The outcome assessor and data analyzer will be blinded with regard to grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.MUI.MED.REC.1399.649
Health conditions studied
1
Description of health condition studied
Myopia
ICD-10 code
H52.13
ICD-10 code description
Myopia, bilateral
2
Description of health condition studied
Astigmatism
ICD-10 code
H52.203
ICD-10 code description
Unspecified astigmatism, bilateral
Primary outcomes
1
Description
Refractive astigmatism
Timepoint
Before, and 6 months after intervention
Method of measurement
Autorefractometry, combined with subjective refinement
Secondary outcomes
1
Description
Visual acuity
Timepoint
Before, and 6 months after intervention
Method of measurement
Snellen chart
2
Description
Cornea slit-lamp examination
Timepoint
before, and 6 months after intervention
Method of measurement
Slit-lamp bio-microscopy
Intervention groups
1
Description
Intervention group: Trans-epithelial PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system.
Category
Treatment - Surgery
2
Description
Control group: Conventional PRK for treatment of myopic astigmatism with SCHWIND AMARIS 1050RS (eye-tech-solutions, Kleinostheim, Germany) excimer laser system aberration free profile.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz hospital
Full name of responsible person
Alireza Peyman
Street address
Modarres Street., Ghods Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
feiz@mui.ac.ir
2
Recruitment center
Name of recruitment center
Parsian Eye Clinic
Full name of responsible person
Alireza Peyman
Street address
No. 210, Mir Street
City
Isfahan
Province
Isfehan
Postal code
8164796653
Phone
+98 31 3662 0704
Email
info@persianeyeclinic.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Research dept., Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
8174674681
Phone
+98 31 3792 7653
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Leila Babaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modares Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
Leila8969@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Peyman
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modares Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
peyman@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Peyman
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modares Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
peyman@med.mui.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
All researchers who are interested
Under which criteria data/document could be used
Selected researchers
From where data/document is obtainable
Contact principal investigator
What processes are involved for a request to access data/document
Maximum one month after contacting the principal investigator