Determining the refractive error of patients (including the amount of sphere and cylinder and cylinder axis) and determining the corrected vision
before and after Trans epithelial Phototherapeutic Keratectomy
Design
The sample size was calculated using G Power software for 30 samples. In this study, there is no control group and therefore there was no need for blinding and the results are compared with studies in the American book.
Settings and conduct
Among the patients referred to the Nikookari Eye Hospital of Tabriz University of Medical Sciences; patients who have undergone refractive surgery and have reduced vision by 2/10 to 9/10 and visual symptoms such as halo or diplopia and in the corneal epithelial map Irregularities in the corneal epithelium are included in the study if desired and with informed consent (TE-PTK) using a Excimer laser with a wavelength of 193 nm using local anesthesia in the operating room. dressing lens is placed and antibiotic and betamethasone drops are started for the patient. Their vision and refraction are measured on the first day and the first and third months. Also, the epithelial map is taken from the patient's cornea after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with reduced vision after refractive surgery and completing the informed consent form to participate in the study
Exclusion criteria:1.collagen diseases and diabetes 2. Eye surface diseases or dry eyes 3. Patients with ocular pathologies
Intervention groups
For patients with reduced vision after refractive surgery by 2/10 to 9/10 and visual symptoms such as halo or diplopia, Transepithelial Phototherapeutic keratectomy(TE-PTK) is performed using a excimer laser and under local anesthesia.
Main outcome variables
Patients' vision before treatment and the first day and the first and third months after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210519051344N2
Registration date:2021-12-24, 1400/10/03
Registration timing:registered_while_recruiting
Last update:2021-12-24, 1400/10/03
Update count:0
Registration date
2021-12-24, 1400/10/03
Registrant information
Name
Afshin Lotfi sadigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3657 7330
Email address
lotfisadigh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-30, 1400/09/09
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Trans Epithelial Phototherapeutic keratectomy (TE_PTK) in correction of irregularities after refractive surgery
Public title
Evaluation of Trans Epithelial Phototherapeutic keratectomy (TE_PTK) in correction of irregularities after refractive surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with low vision after refractive surgery
completing informed consent form to participate in the study
Exclusion criteria:
Collagen vascular diseases and Diabetes
Ocular Surface Disease or Dry eye
Patient with ocular pathology
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Tabriz University of Medical Sciences
Street address
Abbasi street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.TBZMED.REC.1400.808
Health conditions studied
1
Description of health condition studied
Corneal irregularities after Refractive Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Visual acuity
Timepoint
Patients' vision is measured before treatment and on the first day after treatment, as well as the first and third months.
Method of measurement
Snellen Chart
Secondary outcomes
1
Description
Refractive error
Timepoint
Patients'refractive error is measured before treatment and on the first day after treatment, as well as the first and third months.
Method of measurement
Autorefractometer
Intervention groups
1
Description
Among the patients referred to the Nikookari Eye Medical Center of Tabriz University of Medical Sciences, patients who have undergone refractive surgery in the past and have reduced vision by 2/10 to 9/10 and also have visual symptoms such as halo or diplopia, and in the Corneal epithelial mapping is irregular in the corneal epithelium. If desired and with informed consent, they are included in the study. Trans epithelial Phototherapeutic Keratectomy is performed using a excimer laser with a wavelength of 193 nm using local anesthesia in the operating room. During this surgery, the corneal epithelium is removed only in irregular areas and then the excimer laser is applied and the dressing lens and antibiotics and betamethasone drops are started for the patient.Their vision and refraction are measured on the first day and the first and third months. Also, the epithelial map is taken from the patient's cornea after 3 months.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Nikookari Eye Hospital
Full name of responsible person
Afshin Lotfi Sadigh
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 7330 3657
Email
Lotfisadigh@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
Golghasht
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 7310 3335
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
10
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Banafsheh Sarmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 71 3228 8323
Email
b_s524@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Afshin Lotfi Sadigh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 71 3228 8323
Email
Lotfisadigh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hanieh Azizi
Position
Masters
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Abbasi
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۴۶۴۵۳۹۵
Phone
+98 41 7330 3657
Email
Azizih@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available