Protocol summary

Summary
The purpose of this study is to compare the effect of lens removal time in reducing ocular discomfort, accelerating reepithelialization and improving vision after photorefractive keratectomy. This is a single center, not blinded, randomized clinical study with control without placebo. Patients referred to Farabi Eye Hospital for refractive surgery are enrolled in our trial after signing the informed consent. The participants are then divided randomly into two groups by block random sampling. Our inclusion criteria are the general criteria for refractive surgeries and our exclusion criteria are any corneal or main systemic disease. Based on previous studies (α=0.05, power=80%) estimated sample size is n=60. For the experimental group bandage contact lens will be removed seven days after surgery and for the control group bandage contact lens will be removed after four days. In both groups chloramphenicol, betamethasone and diclofenac are administered for the following weeks. On the first day and the lens removal day, we will ask the participants to fill in a questionnaire about the eye discomfort. The questionnaire contains questions about onset of pain, time of maximal pain and the severity of eye discomfort felt in each period of time. On lens removal day, patient will be examined for corneal epithelial defect. On the first, third and sixth month after surgery, visual acuity and corneal haze will be checked. We will also perform aberrometry on the sixth month. We hypothesize better pain control, less ocular discomfort, faster visual recovery and less complication in the intervention group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061613567N3
Registration date: 2013-11-13, 1392/08/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-11-13, 1392/08/22
Registrant information
Name
Mehrdad Mohammadpour
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 6286
Email address
mohammadpour_m@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Eye Research Center, Farabi Hospital
Expected recruitment start date
2013-11-23, 1392/09/02
Expected recruitment end date
2014-02-22, 1392/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of contact lens removal time in inducing pain after photorefractive keratectomy in refractive surgery candidates
Public title
Ideal time for contact lens removal after photorefractive keratectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Over 18 year of age, Less than 0.5 Diopter change in visual acuity in the previous year, Myopia -1.0 to -6.0, Astigmatism 0.75 to 3.0, Hyperopia +1.0to +4.0, Corneal stroma more than 450 micron, Pupil size less than 6mm. Exclusion criteria: Keratoconus, Herpetic keratitis, Corneal dystrophy, Corneal degeneration, Cataract, Glaucoma, Dry eye, Lag ophthalmos, Uveitis, Blepharitis, diabetes, Pregnancy, Breast feeding, Auto immune disease, Immunodeficiency, History of keloid formation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee at Tehran university of medical science
Street address
Qods Ave., Keshavarz Ave., Enghelab Ave., Tehran
City
Tehran
Postal code
Approval date
2013-07-27, 1392/05/05
Ethics committee reference number
92-01-43-19919-90047

Health conditions studied

1

Description of health condition studied
Hyperopia-myopia
ICD-10 code
H54.3
ICD-10 code description
mild or no visual impairment, binocular

Primary outcomes

1

Description
Ocular discomfort (including pain, epiphora, foreign body sensation, blurred vision and photophobia)
Timepoint
Fourth and seventh day post operation
Method of measurement
Questionnaire

2

Description
visual acuity
Timepoint
On the first, third and sixth month after surgery
Method of measurement
snellen chart

3

Description
aberration
Timepoint
Sixth months after surgery
Method of measurement
aberrometry

4

Description
Corneal haze
Timepoint
On the first, third and sixth month after surgery
Method of measurement
Slit lamp

Secondary outcomes

empty

Intervention groups

1

Description
For the experimental group, bandage contact lens is removed 7th day after surgery and three different eye drops are administered for the following weeks : chloramphenicol 0.1% every six hours for four days , betamethasone 0.1% every six hours for two weeks and then tapered over two weeks , diclofenac 0.1% every six hours for a day , additionally for all patients fluorometholone 0.1% is started on the second month , administered every six hours and then tapered off over two months.
Category
Treatment - Other

2

Description
For the control group, bandage contact lens is used right after surgery and removed after 4 days. Three different eye drops are administered for the following week: chloramphenicol 0.1% every six hours for four days, betamethasone 0.1% every six hours for two weeks and then tapered over two weeks , diclofenac 0.1% every six hours for a day. Additionally for all patients fluorometholone 0.1% is started on the second month, administered every six hours and then tapered off over two months.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr.Mehrdad Mohammadpour
Street address
excimer clinic, Farabi hospital, Qazvin Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research tehran university of medical science
Full name of responsible person
Dr. Masoud Younesian
Street address
Seventh floor, Central Organization Building, Qods Ave., Keshavarz Ave., Enghelab Ave. Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research tehran university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of medical science
Full name of responsible person
Mehrdad Mohammad pour
Position
Associate professor
Other areas of specialty/work
Street address
Eye Research Center, Farabi Hospital, Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5542 1006
Fax
Email
mahammadpour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Eye Research Center, Farabi Eye Hospita
Full name of responsible person
Mehrdad Mohammadpour
Position
Anterior Segment & Cornea Fellowship
Other areas of specialty/work
Street address
Farabi eye hospital, Qazvin Sq. , Tehran
City
Tehran
Postal code
Phone
+98 215542100
Fax
Email
mahammadpour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Pegah Hosseini
Position
MD student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Porsina Ave., Keshavarz Blvd., Enghelab Ave.
City
Tehran
Postal code
Phone
0
Fax
Email
pegah_hosseini88@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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