This study is performed to compare the results of two formulations of Riboflavin by Sina Darou, Iran, and Uznach, Switzerland, in corneal collagen cross-linking (CXL) for keratoconus patients. Thirty eyes is compared in each group. The inclusion criterion is the clinical diagnosis of progressive keratoconus with paraclinical confirmation. 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. The intervention is standard collagen cross linking. After removal of the central of the cornea, Iranian (intervention group) or Switzerland (control group) Riboflavin will be prescribed. At first, the method and objectives of the study will be explained to the participants and a written informed consent was obtained from each of them for participation in the study and use of Iranian riboflavin. The patients will be examined before procedure and 1, 3, 6, and 12 months after it.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212034333N2
Registration date:2014-02-25, 1392/12/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-02-25, 1392/12/06
Registrant information
Name
Soheila Asgari
Name of organization / entity
Noor eye hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 1515
Email address
sasgari@noorvision.com
Recruitment status
Recruitment complete
Funding source
Noor Eye Hospital
Expected recruitment start date
2014-04-06, 1393/01/17
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical results of two pharmaceutical products of Riboflavin in corneal collagen Cross-Linking for keratoconus
Public title
Comparison of of two pharmaceutical products of Riboflavin for keratoconus
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Noor Ophthalmology Research Center
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Postal code
1968653111
Approval date
2013-09-18, 1392/06/27
Ethics committee reference number
882/م
Health conditions studied
1
Description of health condition studied
Keratoconus
ICD-10 code
H18.6
ICD-10 code description
Keratoconus
Primary outcomes
1
Description
visual acuity
Timepoint
pre operative and 1, 3, 6, and 12 months after the procedure
Method of measurement
Snellen chart
2
Description
refraction
Timepoint
pre operative and 1, 3, 6, and 12 months after the procedure
Method of measurement
retinoscope
3
Description
corneal topography
Timepoint
pre operative and 1, 3, 6, and 12 months after the procedure
Method of measurement
pentacam
4
Description
corneal rigidity
Timepoint
pre operative and 1, 3, 6, and 12 months after the procedure
Method of measurement
ORA
5
Description
Endothelial cell count
Timepoint
pre operative and 1, 3, 6, and 12 months after the procedure
Method of measurement
non-contact specular microscope
Secondary outcomes
1
Description
Corneal Haze
Timepoint
1, 3, 6, and 12 months after surgery
Method of measurement
Opthalmic examination
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Farhad Rezvan
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Noor Eye Hospital
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
Noor Ophthalmology Research Center
Full name of responsible person
Soheila Asgari
Position
Reasercher
Other areas of specialty/work
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Postal code
Phone
+98 21 8865 1515
Fax
Email
soheilaasgari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Position
PhD student in Ophthalmic Research
Other areas of specialty/work
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Postal code
Phone
+98 21 8865 1515
Fax
Email
soheilaasgari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Position
Researcher
Other areas of specialty/work
Street address
#96 Esfandiar Blvd., Vali’asr Ave.
City
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
soheilaasgari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)