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IRCT201212034333N2 IRCT 2014-02-25 Noor Eye Hospital Comparison of of two pharmaceutical products of Riboflavin for keratoconus Comparison of clinical results of two pharmaceutical products of Riboflavin in corneal collagen Cross-Linking for keratoconus 2014-04-06 anticipated 60 Complete https://irct.ir/trial/4613 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Keratoconus. Intervention 1: Interventional group: After local anaesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouched in between. Another strip will be removed horizontally at the inferior third of the cornea. Then, riboflavin 0.1% drop in dextra 20% (SinaDarou, Iran) will be instilled onto the cornea every 3 minutes for half an hour. At the end of this stage, the patient will be examined by an ophthalmologist to ensure the presence of riboflavin in the anterior chamber. Then, ultraviolet irradiation at a wavelength of 370 nanometer, power 3mW/cm2 and a distance of 5cm will be started. For this purpose, the UVX system (IROC, Zürich, Switzerland) will be used. Ultraviolet irradiation will be continued for 30 minutes, during which, riboflavin instillation will be repeated every 3 minutes. At the end of irradiation, the corneal surface will be rinsed with sterile balanced saline solution, a soft bandage contact lens was placed, and chloramphenicol 0.5% eye drop will be instilled. Treatment will be started with chloramphenicol 0.5% eye drop four times daily, betamethasone 0.1%, and preservative free artificial tears. Patients will be examined on the next day and 3 days after surgery, and the contact lens will be removed if epithelial healing is complete. After removing the contact lens, chloramphenicol will be discontinued and betamethsaone will be continued twice daily for one week and then discontinued. If the epithelial healing will not be complete on the third day, the patient will be visited daily until complete healing. Intervention 2: Control group: After local anesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouched in between. Another strip will be removed horizontally at the inferior third of the cornea. Then, riboflavin (Swiss made) 0.1% drop in dextra 20% (SinaDarou, Iran) will be instilled onto the cornea every 3 minutes for half an hour. At the end of this stage, the patient will be examined by an ophthalmologist to ensure the presence of riboflavin in the anterior chamber. Then, ultraviolet irradiation at a wavelength of 370 nanometer, power 3mW/cm2 and a distance of 5cm will be started. For this purpose, the UVX system (IROC, Zürich, Switzerland) will be used. Ultraviolet irradiation will be continued for 30 minutes, during which, riboflavin instillation will be repeated every 3 minutes. At the end of irradiation, the corneal surface will be rinsed with sterile balanced saline solution, a soft bandage contact lens was placed, and chloramphenicol 0.5% eye drop will be instilled. Treatment will be started with chloramphenicol 0.5% eye drop four times daily, betamethasone 0.1%, and preservative free artificial tears. Patients will be examined on the next day and 3 days after surgery, and the contact lens will be removed if epithelial healing is complete. After removing the contact lens, chloramphenicol will be discontinued and betamethsaone will be continued twice daily for one week and then discontinued. If the epithelial healing will not be complete on the third day, the patient will be visited daily until complete healing.
public Soheila Asgari
#96 Esfandiar Blvd., Vali’asr Ave.
Tehran Iran (Islamic Republic of) +98 21 8865 1515 soheilaasgari@gmail.com Noor Ophthalmology Research Center scientific Soheila Asgari
#96 Esfandiar Blvd., Vali’asr Ave.
Tehran Iran (Islamic Republic of) +98 21 8865 1515 soheilaasgari@gmail.com Noor Eye Hospital Iran (Islamic Republic of) The inclusion criterion is the clinical diagnosis of progressive keratoconus with paraclinical confirmation. The criteria of progressive keratoconus is an increase of at least 1D in maximum keratometry, astigmatism, or manifest refraction, or loss of 2 best corrected visual acuity (BCVA) lines or more in the past 12 months. Patients aged 15-35 years old with keratometry less than 55D and a central corneal thickness less than 400 µ will be selected for the study. Patients with other ocular diseases or a history of ocular surgery will be excluded from the study. Participants discontinue the use of the hard and soft contact lens 3 weeks and 3 days prior to the surgery, respectively. 15 years 35 years Both H18.6 Keratoconus Other Treatment - Drugs Interventional group: After local anaesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouched in between. Another strip will be removed horizontally at the inferior third of the cornea. Then, riboflavin 0.1% drop in dextra 20% (SinaDarou, Iran) will be instilled onto the cornea every 3 minutes for half an hour. At the end of this stage, the patient will be examined by an ophthalmologist to ensure the presence of riboflavin in the anterior chamber. Then, ultraviolet irradiation at a wavelength of 370 nanometer, power 3mW/cm2 and a distance of 5cm will be started. For this purpose, the UVX system (IROC, Zürich, Switzerland) will be used. Ultraviolet irradiation will be continued for 30 minutes, during which, riboflavin instillation will be repeated every 3 minutes. At the end of irradiation, the corneal surface will be rinsed with sterile balanced saline solution, a soft bandage contact lens was placed, and chloramphenicol 0.5% eye drop will be instilled. Treatment will be started with chloramphenicol 0.5% eye drop four times daily, betamethasone 0.1%, and preservative free artificial tears. Patients will be examined on the next day and 3 days after surgery, and the contact lens will be removed if epithelial healing is complete. After removing the contact lens, chloramphenicol will be discontinued and betamethsaone will be continued twice daily for one week and then discontinued. If the epithelial healing will not be complete on the third day, the patient will be visited daily until complete healing. Control group: After local anesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouched in between. Another strip will be removed horizontally at the inferior third of the cornea. Then, riboflavin (Swiss made) 0.1% drop in dextra 20% (SinaDarou, Iran) will be instilled onto the cornea every 3 minutes for half an hour. At the end of this stage, the patient will be examined by an ophthalmologist to ensure the presence of riboflavin in the anterior chamber. Then, ultraviolet irradiation at a wavelength of 370 nanometer, power 3mW/cm2 and a distance of 5cm will be started. For this purpose, the UVX system (IROC, Zürich, Switzerland) will be used. Ultraviolet irradiation will be continued for 30 minutes, during which, riboflavin instillation will be repeated every 3 minutes. At the end of irradiation, the corneal surface will be rinsed with sterile balanced saline solution, a soft bandage contact lens was placed, and chloramphenicol 0.5% eye drop will be instilled. Treatment will be started with chloramphenicol 0.5% eye drop four times daily, betamethasone 0.1%, and preservative free artificial tears. Patients will be examined on the next day and 3 days after surgery, and the contact lens will be removed if epithelial healing is complete. After removing the contact lens, chloramphenicol will be discontinued and betamethsaone will be continued twice daily for one week and then discontinued. If the epithelial healing will not be complete on the third day, the patient will be visited daily until complete healing. Visual acuity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: Snellen chart. Refraction. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: retinoscope. Corneal topography. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: pentacam. Corneal rigidity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: ORA. Endothelial cell count. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: non-contact specular microscope. Corneal Haze. Timepoint: 1, 3, 6, and 12 months after surgery. Method of measurement: Opthalmic examination. Noor Eye Hospital Approved 2013-09-18 Noor Ophthalmology Research Center #96 Esfandiar Blvd., Vali’asr Ave. Tehran Iran (Islamic Republic of)