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IRCT2013060713567N2 IRCT 2013-10-03 vice-chancellor for research Tehran University of Medical Sciences Comparing different artificial tear drops on post operative ocular discomfort after photorefractive keratectomy. Comparative study of two artificial tear drops, hyaluronic acid containing artificial tears versus hyaluronic free artificial tears in controlling post surgical eye discomfort following photorefractive keratectomy . 2013-10-23 anticipated 118 Complete https://irct.ir/trial/13387 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A hyperopia, myopia. Intervention 1: For first experimental group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. For this group Artelac advanced is used as the artificial tear. This is a hyaluronic acid containing artificial tear used every four hours for the first week and then tapered off over three months. Intervention 2: For the second experimental group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. This group will receive preservative free Artelac which is an artificial tear that does not contain hyaluronic acid and is used every four hours in the first week and then tapered off over three months. Intervention 3: For the control group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. Artificial tears are not administered to this group of patients.
public Mehrdad Mohammadpour
Eye Research Center, Farabi hospital, Qazvin Sq.
Tehran Iran (Islamic Republic of) +98 21 5542 1006 mohammadpour_m@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mehrdad Mohammadpour
Farabi eye hospital, Qazvin Sq.
Tehran Iran (Islamic Republic of) +98 21 5542 1006 mahammadpour@yahoo.com Eye Research Center, Farabi hospital Iran (Islamic Republic of) 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. 18 years 60 years Both H54.3 mild or no visual impairment, binocular Treatment - Drugs Treatment - Drugs Treatment - Drugs For first experimental group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. For this group Artelac advanced is used as the artificial tear. This is a hyaluronic acid containing artificial tear used every four hours for the first week and then tapered off over three months. For the second experimental group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. This group will receive preservative free Artelac which is an artificial tear that does not contain hyaluronic acid and is used every four hours in the first week and then tapered off over three months. For the control group, Mitomycin C is used prior to operation, contact lens bandages are used right after surgery and 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. Artificial tears are not administered to this group of patients. Ocular discomfort (including pain, epiphora, foreign body sensation, blurred vision and photophobia). Timepoint: First and fourth day post operation. Method of measurement: Questionnaire. Visual acuity. Timepoint: On the first, third and sixth month after surgery. Method of measurement: Snelen chart. Aberrometry. Timepoint: Sixth months after surgery. Method of measurement: Aberrometer. Corneal haze. Timepoint: On the first, third and sixth month after surgery. Method of measurement: Slit lamp. vice-chancellor for research Tehran University of Medical Sciences Approved 2012-06-10 Research Ethics Committee at Tehran university of medical science Qods Ave., Keshavarz Ave., Enghelab Ave., Tehran Tehran Iran (Islamic Republic of)