|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2013122413567N8 |
|
Date of registration:
|
2014-10-10 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparison of efficacy of two types of contact lenses on reducing pain and discomfort of patients after photorefractive keratectomy
|
|
Scientific title:
|
Comparison of efficacy of two types of silicone hydrogel contact lenses Lotrafilcon B and Balafilcon A after photorefractive keratectomy |
|
Date of first enrolment:
|
2014-04-21 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/13391 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.
|
|
Phase:
|
2-3
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Mehrdad Mohammadpour
|
|
Address:
|
Eye Research Center, Farabi hospital, Qazvin Sq.
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5542 1006 |
|
Email:
|
mohammadpour_m@sina.tums.ac.ir |
|
Affiliation:
|
Tehran University of Medical Sciences |
|
|
Name:
|
Mehrdad Mohammadpour
|
|
Address:
|
Farabi eye hospital, Qazvin Sq.
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5542 1006 |
|
Email:
|
mahammadpour@yahoo.com |
|
Affiliation:
|
Eye Research Center, Farabi hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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
Exclusion criteria:
Age minimum:
19 years
Age maximum:
60 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
myopia, hyperopia.
mild or no visual impairment, binocular
|
|
mild or no visual impairment, binocular
|
|
Intervention(s)
|
|
Treatment - Drugs
|
|
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.
|
|
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
|
|
Intervention 1: 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. Intervention 2: 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.
|
|
Treatment - Other
|
|
Primary Outcome(s)
|
|
Foregin body sensation. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Pain. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Epiphora. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Blurred vision. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Photophobia. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Secondary Outcome(s)
|
|
Satisfaction. Timepoint: 1st postoperative day, 3rd postoperative day. Method of measurement: Questionnaire.
|
|
Source(s) of Monetary Support
|
|
Vice-Chancellor for research of Tehran University of Medical Sciences
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Research Ethics Committee at Tehran university of medical science
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|