Comparison of conventional and transepithelial methods of epithelial debridement in photorefractive keratectomy in terms of postoperative recovery rate
Design
Randomized clinical trial, 2 parallel and double-blinded groups
Settings and conduct
Patients with myopia and myopia astigmatism candidates for PRK using the Amaris eximer laser at Noor eye Hospital will be randomly assigned to one of two intervention groups using a randomization blocks table. Epithelial defect imaging will be performed on the day of surgery immediately following the surgery, and on consecutive days after surgery until wound healing. Epithelial defect area in each image will be calculated using an image processing software. Also, on postoperative day 1, 3 and 7, a standardized questionnaire will be used to assess pain severity and symptoms in each eye. Three months later, the patient is examined for visual acuity, refraction, and haze.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: age between 18 to 50 years; equivalent sphere at least -2.00 diopter with astigmatism up to -4.00 diopter and myopia up to -8.00 diopter; stability of refraction for at least one year before surgery;
corrected visual acuity more than 20/30.
Contact lens use should be discontinued at least 3 weeks prior to surgery.
Exclusion criteria include any eye pathology including corneal dystrophy, keratoconus or keratoconus suspect, glaucoma or glaucoma suspect; and a history of diabetes, autoimmune diseases and any previous ophthalmic surgery.
Intervention groups
Group 1: One eye is operated by Trans PRK and the other one by Mechanical PRK
Group 2: One eye is operated by Trans PRK and the other by Alcohol-assisted PRK
Main outcome variables
The healing rate of corneal epithelial defect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200317046804N1
Registration date:2020-05-05, 1399/02/16
Registration timing:registered_while_recruiting
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Azam Alvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8240 1634
Email address
a-alvani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of conventional and transepithelial photorefractive keratectomy in myopic and myopic astigmatism patients
Public title
Conventional and transepithelial PRK
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Equivalent sphere at least -2.00 diopter with astigmatism up to -4.00 diopter and myopia up to -8.00 diopter.
The stability of refraction for at least one year before surgery.
Corrected visual acuity more than 20/30.
Contact lens use should be discontinued at least 3 weeks prior to surgery.
age between 18 to 50 years
Exclusion criteria:
Any ocular pathology including corneal dystrophy, keratoconus or keratoconus suspect and glaucoma or glaucoma suspect.
The history of diabetes and autoimmune diseases.
The history of any previous ocular surgery.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Both eyes of patients with bilateral myopia and/or myopic astigmatism.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done using permuted-block randomization method and based on a block size of 4. The random sequence of blocks will be obtained from the random number table. In the first stage, patients will be assigned to one of the two intervention groups A and B, and in the second stage, it will be randomized to determine which eye will be operated on by transepithelial method. Allocation concealment will be performed by sequentially numbered, sealed, opaque envelopesa.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of which group they are in. People who do the tests (optometrist and clinical ophthalmologist) will also be unaware of which intervention group they are evaluating.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of the University, Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417733161
Approval date
2020-04-30, 1399/02/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.033
Health conditions studied
1
Description of health condition studied
Corneal epithelium debridement in Photorefractive keratectomy
ICD-10 code
H17.8
ICD-10 code description
Other corneal scars and opacities
Primary outcomes
1
Description
Corneal epithelial defect size
Timepoint
Day of operation and consecutive days after surgery until complete healing of corneal epithelial defect (at least 3 and up to 7 days)
Method of measurement
Using photoslit
Secondary outcomes
1
Description
Severity of patient's pain and discomfort due to corneal epithelial defect
Timepoint
Consecutive days after surgery until complete healing of corneal epithelial defect (at least 3 and up to 7 days)
Method of measurement
11-Point numeric scale of pain Questionnaire and Eye sensation scale Questionnaire
2
Description
Non-corrected and corrected VA
Timepoint
Preoperation and 3 month after operation
Method of measurement
Snellen Chart
3
Description
Refraction
Timepoint
Preoperation and 3 month after operation
Method of measurement
Autorefractometer
Intervention groups
1
Description
Intervention group 1: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed mechanically by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand.
Category
Treatment - Surgery
2
Description
Intervention group 2: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed using alcohol and by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Eye Hospital
Full name of responsible person
Azam Alvani
Street address
No. 96, Esfandiar Blvd, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1631
Fax
+98 21 8865 1514
Email
alvani63@gmail.com
Web page address
http://www.norc.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Dr. Seyed Hasan Hashemi
Street address
No. 96, Esfandiar Blvd, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
research@norc.ac.ir
Web page address
http://www.norc.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Noor Eye Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Azam Alvani
Position
PhD student of ophthalmology clinical sciences
Latest degree
Master
Other areas of specialty/work
Optometrist
Street address
No. 96, Esfandiar Blvd, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1631
Fax
+98 21 8865 1514
Email
alvani63@gmail.com
Web page address
http://www.norc.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Dr. Seyed Hasan Hashemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
No. 96, Esfandiar Blvd, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
research@norc.ac.ir
Web page address
http://www.norc.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Azam Alvani
Position
PhD student of Ophthalmology Clinical Sciences
Latest degree
Master
Other areas of specialty/work
Optometrist
Street address
No. 96, Esfandiar Blvd, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1631
Fax
+98 21 8865 1514
Email
alvani63@gmail.com
Web page address
http://www.norc.ac.ir/
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 are no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available