effect of balanced salt solution temperatures ( 24 degree & 0 degree) on pain control after photorefractive keratectomy
Design
This is a contralateral clinical trial and is conducted on 116 eligible patients. For randomization, the lottery method is used in such a way that two completely folded papers are placed in a container. The left eye is written on one paper and the right eye is written on the other paper. In another container, two folded papers are placed, on one paper the control group is written and on the other paper, the intervention group is written. After mixing, he takes a piece of paper from each container and surgery will be performed based on the content of the paper.
Settings and conduct
this study is carried out in a period of 6 months in khatam al_anbia hospital in mashhad.
Participants/Inclusion and exclusion criteria
inclusion criteria include patients aged 20 to 40 years and patients with myopia and myopic astigmatism
exclusion criteria include patients with a history of diabetes and rheumatology diseases and smoking & opioid use .
Intervention groups
this contralateral study is conducted on 116 selected patient . the study is that in one eye during and after photorefractive keratectomy balanced salt solution is poured at room temperature and in the other eye BSS at zero degree temperature is poured.
Main outcome variables
The degree of pain after photorefractive keratectomy, the degree of restoration of the corneal epithelium after photorefractive keratectomy, the degree of inflammation and redness of the conjunctiva after photorefractive keratectomy and the patient's refraction after photorefractive keratectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231114060059N1
Registration date:2025-11-18, 1404/08/27
Registration timing:retrospective
Last update:2025-11-18, 1404/08/27
Update count:0
Registration date
2025-11-18, 1404/08/27
Registrant information
Name
hossein hajizade juybary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4254 6171
Email address
hosseinhajizade6171@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of balanced salt solution temperatures in pain control and corneal epithelium healing after photorefractive keratectomy
Public title
Investigating the effect of balance salt solution temperature zero degrees on pain control after photorefractive keratectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pation with myopia and myopic astigmatism
the degree of myopia is 1 to 5 diopters
the amount of astigmatism is 0 to 4 diopters
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
116
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
the researcher is unaware of solutions temperature
but the patient and outcome assessor are informed about the temperature.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Gharani Blvd, khatam ol anbia hospital
City
Mashad
Province
Razavi Khorasan
Postal code
۹۱۹۵۹۶۴۶۴۵
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1403.066
Health conditions studied
1
Description of health condition studied
Refractive error
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain level after photorefractive keratectomy
Timepoint
Within 5 days after photorefractive keratectomy
Method of measurement
Pain level after photorefractive keratectomy based on visual analogue scale in 6 hours after photorefractive keratectomy and on days 1, 3 and 5 after photorefractive keratectomy
2
Description
Corneal epithelium repair rate after photorefractive keratectomy
Timepoint
Within 5 days after photorefractive keratectomy
Method of measurement
The amount of epithelium repair based on the remaining defect area with Slate Photo on days 1, 3 and 5 after photorefractive keratectomy
Secondary outcomes
empty
Intervention groups
1
Description
In this study, in one patient's eye, room temperature balanced salt solution is poured during and after photorefractive keratectomy (control group) and in the other eye, zero degree balanced salt solution is poured during and after photorefractive keratectomy (intervention group).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam ol anbia hospital
Full name of responsible person
mohammadreza sedaghat
Street address
shahid gharani blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9195964645
Phone
+98 51 3728 1401
Email
sedaghatMR@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohamadreza sedaghat
Street address
shahid gharani blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9195964545
Phone
+98 51 3728 1401
Email
sedaghatMR@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
mohamadreza sedaghat
Position
ophthalmologist cornea fellowship professor of ophthalmologhy mashhad university of medical sciences
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
shahid gharani blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9195964645
Phone
+98 51 3728 1401
Email
sedaghatMR@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohamadreza sedaghat
Position
ophthalmologist cornea fellowship professor of ophthalmology mashhad university of medical scienes
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
shahid gharani blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9195964545
Phone
+98 51 3728 1401
Email
sedaghatMR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohamadreza sedaghat
Position
ophthalmologist cornea fellowship professor of ophthalmologhy mashhad university of medical sciences
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
shahid gharani blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9195964645
Phone
+98 51 3728 1401
Email
sedaghatMR@mums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available