The purpose of this study is to compare the efficacy of two silicone hydrogel bandage contact lenses Lotrafilcon B and Balafilcon A in reducing pain and ocular discomfort after photorefractive keratectomy. This study is a double blinded clinical trial without control group. Patients willing to go under photorefractive surgery will enter the trial after signing the informed consent. Inclusion criteria are basically the criteria for refractive surgery. Exclusion criteria are any systemic or corneal disease. Based on previous studies and considering a=0.05, sample size was estimated to be 120 eyes. After the surgery, Lotrafilcon B contact lens was fitted in one eye of each patient and Balafilcon A contact lens in the fellow eye. The patients were asked to answer a questionnaire on the first and third day after surgery about the onset of pain, the time of maximum pain, severity of ocular symptoms( pain, epiphora, foreign body sensation, blurred vision, photophobia) and overall satisfaction from 0 to 10. The examiner will remain blinded to patients' lens type through the study. Blinding will also be done in analyzing. After gathering the data, the efficacy of aforementioned lenses will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122413567N8
Registration date:2014-10-10, 1393/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
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
2014-04-21, 1393/02/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of two types of silicone hydrogel contact lenses Lotrafilcon B and Balafilcon A after photorefractive keratectomy
Public title
Comparison of efficacy of two types of contact lenses on reducing pain and discomfort of patients after photorefractive keratectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 19 to 40 years old; refraction stability of at least 1 year; myopia of 8 diopter or less/astigmatism of 6 diopter or less; minimum corneal thickness of 480 micrometer in ultrasound pachymetry; minimum residual stromal thickness of 420 micrometer; corrected distant visual acuity equal or more than 20/20
Exclusion criteria: Ocular diseases such as cataract and glaucoma; corrected distant visual acuity of less than 20/20; diseases that could delay recovery such as diabetes mellitus, collagen vascular diseases, autoimmune diseases, herpetic eye infection and immune deficiency; history of colloid formation following previous surgeries
Age
From 19 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double 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
University's central building, Qods Ave., Keshavarz Ave., Enghelab Ave.
City
Tehran
Postal code
Approval date
2014-04-18, 1393/01/29
Ethics committee reference number
114/130/د/93
Health conditions studied
1
Description of health condition studied
myopia, hyperopia
ICD-10 code
H54.3
ICD-10 code description
mild or no visual impairment, binocular
Primary outcomes
1
Description
Pain
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
2
Description
Epiphora
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
3
Description
Foregin body sensation
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
4
Description
Blurred vision
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
5
Description
Photophobia
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Satisfaction
Timepoint
1st postoperative day, 3rd postoperative day
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: consists of one eye of each patient which is fitted with Lotrafilcon B silicone hydrogel contact lens (Air Optix®AQUA, Ciba Vision, Duluth, GA, USA) by a surgeon who is aware of the type of contact lenses after photorefractive keratectomy. The bandage contact lens will be removed after complete reepithelialization. Postoperative protocol includes Betamethasone eye drop 4 times daily which will be tapered over 3 weeks and changed to Fluorometholone 0.1% eye drop and Chloramphenicol eye drop 4 times daily for 5 days.
Category
Treatment - Other
2
Description
Intervention group 2: consists of one eye of each patient which is fitted with Balafilcon A silicone hydrogel contact lens (PureVision™ Bausch & Lomb, Rochester, NY, USA) by a surgeon who is aware of the type of contact lenses after photorefractive keratectomy. The bandage contact lens will be removed after complete reepithelialization. Postoperative protocol includes Betamethasone eye drop 4 times daily which will be tapered over 3 weeks and changed to Fluorometholone 0.1% eye drop and Chloramphenicol eye drop 4 times daily for 5 days
Category
Treatment - Drugs
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 of Tehran University of Medical Sciences