To compare the anti-inflammatory efficacy and safety of Fluorometholone 0.1% versus Loteprednol 0.5% following photorefractive keratectomy.
Design
This study is a simple randomized and triple-blinded controlled trial (phase 3) with parallel groups that was conducted on both of eyes of 100 patients. Fluorometholone and Loteprednol were allocated to Intervention and control group.
Settings and conduct
This study was performed in Feiz hospital in Isfahan, Iran. To compare two eye drops of Fluorometholone 0.1% and Luteinprenol 0.5%, both eyes of 100 photorefractive keratectomy patients were randomized allocated for the intervention and control groups (triple blinded that all members of the research team except the clinical pharmacist were unaware of the content of the droppers).Fluorometholone and Loteprednol were allocated to Intervention and control group. The informed consent was obtained from each participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Stable refraction error for at least 12 months; Myopia between −1.0 to −8.0 diopters; Astigmatism less than 4.0 diopters; Normal eye examination
Exclusion criteria:
Unwillingness to participate or continue; administration of another topical medication; need to increase the topical steroid dosage; and treatment-related complications.
Intervention groups
Intervention group was allocated to use of Fluorometholone 0.1% one drop every 6 hour for one month and control group received the Loteprednol 0.5% sterile ophthalmic suspension one drop every 6 hour for one month.
Main outcome variables
Best corrected distance visual acuity; corneal optical density.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131229015975N6
Registration date:2020-02-06, 1398/11/17
Registration timing:retrospective
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Mohsen Pourazizi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 1385
Email address
m.pourazizi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
2016-04-02, 1395/01/14
Actual recruitment end date
2016-07-31, 1395/05/10
Trial completion date
2017-04-03, 1396/01/14
Scientific title
Clinical efficacy of Fluorometholone versus Loteprednol eye drops after photorefractive keratectomy: A triple-blinded randomized clinical trial
Public title
efficacy of Fluorometholone versus Loteprednol eye drops after photorefractive keratectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stable refraction error for at least 12 months
Myopia between −8.0 to −1.0 diopters
Astigmatism less than 4.0 diopters
Normal eye examination
Exclusion criteria:
Unwillingness to participate or continue
administration of another topical medication
need to increase the topical steroid dosage
treatment-related complications
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
The study was conducted on both eyes of 100 patients that were randomly allocated to the intervention and control groups.
Actual sample size reached:
100
More than 1 sample in each individual
Actual sample size in each individual:
2
The study was conducted on both eyes of 100 patients that were randomly allocated to the intervention and control groups.
Randomization (investigator's opinion)
Randomized
Randomization description
Both eyes in each subject were randomly allocated to the Fluorometholone (FML) and Loteprednol etabonate (LE) groups using software (Saghaei random allocation software) and simple randomization. According to the random table, each eye individually assigned to one group and the other to the second group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All patients and members of the research team who were involved the study were blinded to the contents of the eye drops. Only the clinical pharmacy
technician was aware of the content of each of the eye drops.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Deputy of Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-05-26, 1395/03/06
Ethics committee reference number
395477
Health conditions studied
1
Description of health condition studied
Myopia correction by photorefractive keratectomy
ICD-10 code
H52.10
ICD-10 code description
Myopia, unspecified eye
2
Description of health condition studied
Astigmatism correction by photorefractive keratectomy
ICD-10 code
H52.20
ICD-10 code description
Unspecified astigmatism
Primary outcomes
1
Description
Change in best corrected distance visual acuity (BCDVA)
Timepoint
Before intervention and on days one, three, and five and then at months one and three postoperatively.
Method of measurement
Eye examination, slit-lamp biomicroscopy and fundus examination assessment
2
Description
Corneal optical density
Timepoint
Before intervention and on days one, three, and five and then at months one and three postoperatively.
Method of measurement
Corneal densitometry was performed with a rotating camera cornea tomography system (Pentacam®).
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
Before intervention and on days one, three, and five and then at months one and three postoperatively.
Method of measurement
Goldman applanation tonometry (GAT)
2
Description
Side effects
Timepoint
On days one, three, and five and then at months one and three postoperatively.
Method of measurement
Clinical assessment
Intervention groups
1
Description
Intervention group: One eye in each subject was randomly allocated to use of 0.1% Fluorometholone eye drops packaged in droppers (Floucort®, SinaDarou Co., Tehran, Iran) that was prescribed one drop every 6 h for one month.
Category
Treatment - Drugs
2
Description
Control group: The another eye in each subject was randomly allocated to use of the 0.5% Loteprednol sterile ophthalmic suspension packaged in identical droppers (Lotemax®, Bausch & Lomb Inc., Rochester, NY, USA) that was prescribed one drop every 6 hour for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Ali Salehi
Street address
Feiz hospital, Modarres Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8165647194
Phone
+98 31 3445 2031
Email
salhi109@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Research and Technology Deputy of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3061
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
Mohsen Pourazizi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modarres Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8165647194
Phone
+98 31 3445 2031
Email
m.pourazizi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hasan Razmjoo
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modarres Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
razmjoo@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Mikaniki
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modarres Ave., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8165647194
Phone
+98 31 3445 2031
Email
m.mikaniki76@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Primary outcome data can be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Descriptive analysis is allowed on requested data
From where data/document is obtainable
Mohsen Pourazizi, Department of Ophthalmology, Isfahan University of Medical Sciences, Isfahan, Iran Email: m.pourazizi@yahoo.com
What processes are involved for a request to access data/document
The request is discussed in the Center Committee and after approval, the data is submitted to the applicant over a period of approximately one month.