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Oral Ascorbate Effect on Corneal Epithelial Healing Time and Haze Formation After Trans_epithelial Photorefractive Keratectomy

Protocol summary

Study aim
Effect of Oral Ascorbate on Corneal Epithelial Quality, Corneal Epithelial Healing Time, Corneal Haze Healing and quantity of patients'pain after Trans_epithelial Photorefractive Keratectomy
Design
A randomized clinical trial including two groups (Control group, intervention group), factorial and randomized with blinded outcome assessment, phase3 enrolled for 160 patients by block randomization method by computer.
Settings and conduct
Before surgery, all necessary examinations and paraclinical assessments will be done for all candidated patients; also assessments will be done repeatedly in weeks: 1, 2 and months: 2, 3 after surgery.
Participants/Inclusion and exclusion criteria
Conditions for Entering the Study: patients candidates for TPRK during the 2022,Junel; pateints'eye score must be stable for at least one year; pateints must be more than 18 and less than 50 years old; because this surgery is completely elective, both this surgery and using vitamin_c must be based on the patient's decisions. Conditions for not entering the study: despite the sufficient and comprehensive explanations, the patients were not interested in participating the study; the patient is dead or suffers from another proved disease.
Intervention groups
Group A as *case control* will only receive the common treatment after the surgery which includes using bethamethasone and cloramphenicole drops, 1 drop every 6 hours till the first week after surgery and flucort drop till 10 weeks after surgery (reducing dose after every 2 weeks). Group B as *intervention group* will receive oral chewing tablets of vitamin C 500mg every 6 hours during the first three days after surgery along with the common treatment.
Main outcome variables
The main outcome of the study is to survey the relationship between vit_C and healing cornea epithelium after TPRK.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220601055053N1
Registration date: 2022-06-20, 1401/03/30
Registration timing: retrospective

Last update: 2022-06-20, 1401/03/30
Update count: 0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
Niloofar Hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3254 8630
Email address
niloohjz7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral Ascorbate Effect on Corneal Epithelial Healing Time and Haze Formation After Trans_epithelial Photorefractive Keratectomy
Public title
Oral Vitamin_C Effect in Treatment of Cornea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidated for TPRK during the 2022, June Patients' eye score must be stable for at least one year Patients must be more than 18 and less than 50 years old Because this surgery is completely elective,both this surgery and using vitamin_c must be based on the patient's decisions
Exclusion criteria:
The patients were not interested in participating the study despite the comprehensive and complete explanations. The patient is dead or get another proved disease such as collagen vascular diseases,romatoid arthritis,glandular diseases (hypo/hyper thyroidism and hypo/hyper parathyroidism),diabetes mellitus,hypertension,marfan syndrome,herpes keratitis,infectious diseases(HIV,hepatitis),cataract or any other past noticable ophthalmic disease or surgery that destroy the results of study in a way that examination can not be compared and assessed.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into two groups using BLOCK RANDOMIZATION method by the surgical technician(that is present in all surgeries) and the surgeon is not aware of the patients'placement in each group.The patients will be randomly divided into equal numbers by computer.From this number , groupA as case control will only receive the common treatment after the surgery which includes using betamethasone and chloramphenicol drops, 1drop every 6hours till the first week after surgery and fluocort drop till 10 weeks after surgery(reducing dose after every 2weeks).groupB as intervention group will receive oral tablets of vitamin C 500mg every 6hours during the first three days after surgery along with the common treatment.It is necessary to mention that the patients will be explained that they don't need to use any other combinations including vitamin C.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients are randomly divided into two groups with equal number of patients by computer using BLOCK RANDOMIZATION method by the surgical technician(that is present in all surgeries) and the surgeon and the researcher are not aware of the patients'placement in each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square
City
Karaj
Province
Alborz
Postal code
3155734541
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.ABZUMS.REC.1401.053

Health conditions studied

1

Description of health condition studied
Effect of Ascorbate on Healing Cornea Epithelium after Trans_epithelial Photorefractive Keratectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Corneal Epithelial Healing Time
Timepoint
Before the surgery,1week, 2weeks, first, second, third months after surgery
Method of measurement
slit lamp

2

Description
Corneal Haze Formation
Timepoint
Before the surgery,1week, 2weeks, first, second, third months after surgery
Method of measurement
slit lamp

3

Description
Crneal Epithelial Healing Quality
Timepoint
Before the surgery,1week, 2weeks, first, second, third months after surgery
Method of measurement
slit lamp

4

Description
The Quantity of Patient's Pain after Surgery
Timepoint
Before the surgery,1week, 2weeks, first, second, third months after surgery
Method of measurement
The McGill Pain Questionnaire(MPQ)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: they will only receive the common treatment after the surgery which includes using bethamethasone and cloramphenicole drops, 1drop every 6hours till the first week after surgey and flucort drop till 10 weeks after surgery(reducing dose after every 2weeks).
Category
Treatment - Drugs

2

Description
Intervention group: they will receive oral chewing tablets of vitamin C 500 mg produced by Simorgh Daru Attar Pharmaceutical indaustry every 6hours during the first three days after surgery along with the common treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alborz Central Special Clinic
Full name of responsible person
Niloofar Hejazi
Street address
Floor2, Mahdieh Street, Tohid Square
City
Karaj
Province
Alborz
Postal code
3155734541
Phone
+98 26 3254 8630
Fax
+98 901 747 4592
Email
niloohjz7@gmail.com

2

Recruitment center
Name of recruitment center
Karaj Shahid Madani Hospital
Full name of responsible person
Niloofar Hejazi
Street address
Shahid Madani Square, Mahan Blvd., Jahanshahr
City
Karaj
Province
Alborz
Postal code
3155734541
Phone
+98 26 3444 2070
Email
niloohjz7@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Hatam Godini
Street address
Research assistant,Saffarian Alley,Golshahr district
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Niloofar Hejazi
Position
medicine student(intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square
City
Karaj
Province
Alborz
Postal code
3155734541
Phone
+98 26 3254 8630
Email
niloohjz7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Niloofar Hejazi
Position
medicine student(intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square
City
Karaj
Province
Alborz
Postal code
3155734145
Phone
+98 26 3254 8630
Email
niloohjz7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Niloofar Hejazi
Position
medicine student(intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square
City
Karaj
Province
Alborz
Postal code
3155734541
Phone
+98 26 3254 8630
Email
niloohjz7@gmail.com

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
This survey is such a statistical analysis and our purpose is releasing the inclusion in group results.Personal identities and personal results of patients are unnecessary.
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Final data will be published only as group result.
When the data will become available and for how long
The Results of this survey will be accesible 3months after publishment.
To whom data/document is available
All the university researchers and also all other applicants in indusries can send request for access to Final data.
Under which criteria data/document could be used
Other completing statistical analysis can be done if the researcher of this survey agreed after cosultment.
From where data/document is obtainable
Applicants can seend request to the below email address which is for(Dr.Niloofar Hejazi): niloohjz@gmail.com
What processes are involved for a request to access data/document
Applicant's emails will be answered at last during one week.
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