This is a double-blinded-parallel randomised clinical trial to compare continuous-light versus pulsed-light accelerated corneal cross-linking for keratoconus patients in the Ordibehesht hospital and Salouti eye-clinic. The patients, statistician, and staffs for data-gathering wiii be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Progressive keratoconus (Progression of the disease was considered as confirmed if the loss of corrected distance visual acuity (CDVA) was more than one line in 1 year, or when the topographic keratometry increased by >1.0 D in 6 months or >2.0 D in 12 months); The thinnest central corneal thickness (CCT) >400 µm. Non-inclusion criteria: patients who wear contact lenses for one month prior to the initial evaluation and treatment; Patients with immune system disorders; Patient with corneal scar; Patient with history of herpes simplex keratitis; Pregnant or breastfeeding women
Intervention groups
Intervention group 1: (continuous-light accelerated CXL group); Accelerated CXL with continuous-light using 9 mW/cm2 for 10 minutes .
Intervention group 2: (pulsed-light accelerated CXL group); Accelerated CXL with pulsed on/off light using 9 mW/cm2 for 20 minutes.
Both irradiation protocols used a commercially available device (UV-360, New Vision, Inc.) with a 5 cm working distance and an 8.0 mm aperture.
Main outcome variables
Best corrected spectacle visual acuity (BSCVA)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190508043529N1
Registration date:2019-08-15, 1398/05/24
Registration timing:registered_while_recruiting
Last update:2019-08-15, 1398/05/24
Update count:0
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
Ramin salouti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 1127
Email address
saloutir@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Continuous-light versus pulsed-light accelerated corneal crosslinking with ultraviolet-A and riboflavin in keratoconus patients
Public title
corneal crosslinking in keratoconus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Progressive keratoconus (Progression of the disease was considered as confirmed if the loss of corrected distance visual acuity (CDVA) was more than one line in 1 year, or when the topographic keratometry increased by >1.0 D in 6 months or >2.0 D in 12 months)
The thinnest central corneal thickness (CCT) >400 µm
Exclusion criteria:
Patients who wear contact lenses for one month prior to the initial evaluation and treatment
Patients with immune system disorders
Patients with corneal scar
Patients with history of herpes simplex keratitis
Patients who were pregnant or breastfeeding
Age
From 6 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the block-randomization methods with blocks of size 4, patients will be randomly assigned to both intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Statistician, and data collector will be kept blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
1234567890
Approval date
2019-04-09, 1398/01/20
Ethics committee reference number
IR.SUMS.REC.1398.241
Health conditions studied
1
Description of health condition studied
Keratoconus
ICD-10 code
H18.6
ICD-10 code description
Keratoconus
Primary outcomes
1
Description
Best corrected spectacle visual acuity (BSCVA)
Timepoint
6 months after intervention
Method of measurement
E-chart
Secondary outcomes
1
Description
Keratometric indices
Timepoint
6 months after intervention
Method of measurement
Pentacam
2
Description
Biomechanical parameters
Timepoint
6 months after intervention
Method of measurement
Corvis
Intervention groups
1
Description
Intervention group 1: (continuous-light accelerated CXL group); Accelerated CXL with continuous-light using 9 mW/cm2 for 10 minutes .
Category
Treatment - Surgery
2
Description
Intervention group 2: (pulsed-light accelerated CXL group); Accelerated CXL with pulsed on/off light using 9 mW/cm2 for 10 minutes.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Salouti eye clinic
Full name of responsible person
Ramin Salouti
Street address
Sattarkhan street
City
Shiraz
Province
Fars
Postal code
7183933636
Phone
+98 71 3629 1127
Fax
+98 71 3629 1127
Email
saloutir@hotmail.com
Web page address
http://www.saloutieyeclinic.com
2
Recruitment center
Name of recruitment center
Ordibehesht hospital
Full name of responsible person
Ramin Salouti
Street address
Chamran street
City
Shiraz
Province
Fars
Postal code
7183933636
Phone
+98 71 3629 1127
Fax
+98 71 3629 1127
Email
saloutir@hotmail.com
Web page address
http://www.ordibeheshthospital.ir/Home.aspx?lng=2
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Masihpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3629 1127
Fax
+98 71 3629 1127
Email
nasrin.masihpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Masihpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3629 1127
Fax
+98 71 3629 1127
Email
nasrin.masihpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Masihpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
1234567890
Phone
+98 71 3629 1127
Fax
+98 71 3629 1127
Email
nasrin.masihpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be achieved upon reasonable request sent to corresponding authors.
When the data will become available and for how long
Starting 2 years after publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Data can be achieved upon reasonable request sent to corresponding authors.
From where data/document is obtainable
Department of Ophthalmology, Shiraz University of medical sciences, Dr. Ramin Salouti: saloutir@hotmail.com
What processes are involved for a request to access data/document
Data can be achieved upon reasonable request sent to corresponding authors.
Department of Ophthalmology, Shiraz University of medical sciences, Dr. Ramin Salouti: saloutir@hotmail.com