Comparison of effects & complications of CCL surgery with 2 methods of Epithelium removal & Trans Epithelial with using DAYA epithelium disruptor: A Randomized-Controlled Clinical Trial
This study is designed to evaluate and compare safety & efficacy of Collagen Cross-Linking with 2 methods of Epithelium removal(Conventional Method) & Trans Epithelial with using DAYA epithelium disruptor. 50 patients of binocular Keratoconus of two centers of Poostchi & Motahari with age ≤ 25 years and/or with progression at age› 25 years were included. Variables like Uncorrected and corrected visual acuity, Keratoconus indices according to Pentacam® imaging and endothelial cell count are measured. With stratified randomization, first the eyes and then in each group, one of the methods is chosen, undergo the procedure and the next eye undergone the other method, 2 weeks later. Inclusion Criteria: Those with Rabinowitz criteria of keratoconus of both eyes; age ≤ 25 years; increase of at least 1 diopter of Kmax within last 12 months for age › 25 years. Exclusion criteria: Corneal Thickness of less than 400 microns; Kmax more than 61D; previous herpetic infection; Concurrent keratitis; Severe corneal opacity; history of poor epithelial healing; Autoimmune diseases; Severe ocular surface diseases. Both the patient and the analyzer are blind to the type of the method used for each eye. After one year of follow up, abovementioned variables are measured again and undergone analysis.
General information
Acronym
CCLRD
IRCT registration information
IRCT registration number:IRCT2016112231028N1
Registration date:2017-03-29, 1396/01/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-29, 1396/01/09
Registrant information
Name
Seyed Mohammad Salar Zaheryani
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 1510
Email address
smszaheryany@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-02-15, 1395/11/27
Expected recruitment end date
2018-03-15, 1396/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects & complications of CCL surgery with 2 methods of Epithelium removal & Trans Epithelial with using DAYA epithelium disruptor: A Randomized-Controlled Clinical Trial
Public title
Comparison of effects & complications of Collagen Cross-Linking surgery with 2 methods of Epithelium removal & Trans Epithelial with using DAYA epithelium disruptor: A Randomized- Controlled Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Those with Rabinowitz criteria of keratoconus of both eyes; age ≤ 25 years; increase of at least 1 diopter of Kmax within last 12 months for age › 25 years.
Exclusion criteria: Corneal Thickness of less than 400 microns; Kmax more than 61D; previous herpetic infection; Concurrent keratitis; Severe corneal opacity; history of poor epithelial healing; Autoimmune diseases; Severe ocular surface diseases.
Age
From 18 years old to 46 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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
Committee of ethics in research of school of medicine
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.SUMS.MED.REC.1395.72
Health conditions studied
1
Description of health condition studied
keratoconus
ICD-10 code
H18.6
ICD-10 code description
No description was found
Primary outcomes
1
Description
K max
Timepoint
pre and post op
Method of measurement
Using pentacam imaging
2
Description
Time required for reepithelialization
Timepoint
post op, at days 1-3-5 & 7
Method of measurement
Slit lamp exam
3
Description
Uncorrected Visual acuity
Timepoint
pre and post op
Method of measurement
Physical exam
4
Description
Corrected Visual Acuity
Timepoint
pre and post op
Method of measurement
Physical exam
5
Description
Endothelial Cell Count
Timepoint
pre and post op
Method of measurement
Specular Microscopy
Secondary outcomes
1
Description
Sterile corneal infiltration
Timepoint
post op
Method of measurement
physical exam
2
Description
keratitis
Timepoint
post op
Method of measurement
physical exam
3
Description
corneal scar
Timepoint
post op
Method of measurement
physical exam
Intervention groups
1
Description
Control Group: Corneal epithelium is removed completely by FUKASAKU Hockey Knife and then standard solution of riboflavin 0.1% with intervals of 3 minutes distilled into eye for 30 min. Then with irradiation of UV-A with wavelength of 365-370 nm & power of 9mW/cm2 and short distance from the eye (about 5 cm) for 10 min, distillation continued. Finally, irrigation with 30 ml of BSS and applying therapeutic lens over the eye, the procedure is completed.
Category
Treatment - Surgery
2
Description
Intervention Group: Corneal epithelium is disrupted incompletely by DAYA epithelial disruptor and then standard solution of riboflavin 0.1% with intervals of 3 minutes distilled into eye for 30 min. Then with irradiation of UV-A with wavelength of 365-370 nm & power of 9mW/cm2 and short distance from the eye (about 5 cm) for 10 min, distillation continued. Finally, irrigation with 30 ml of BSS and applying therapeutic lens over the eye, the procedure is completed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Poostchi Ophthalmology Center
Full name of responsible person
Dr M. Hossein Norozzadeh
Street address
Zand Street
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Motahhari Poly Clinic
Full name of responsible person
Dr Hossein Jamali
Street address
Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Masoom Masoompour
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
S.M. Salar Zaheryani
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Khalili Hospital
City
Shiraz
Postal code
Phone
+98 71 3234 1510
Fax
Email
smszaheryany@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
S.M. Salar Zaheryani
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Khalili Hospital
City
Shiraz
Postal code
Phone
+98 71 3234 1510
Fax
Email
smszaheryany@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
S.M. Salar Zaheryani
Position
Resident Of Ophthalmology
Other areas of specialty/work
Street address
Kalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 713234510
Fax
Email
smszaheryany@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)