Comparison of one-year efficacy of accelerated cross-linking (9 mW/cm2, 10 min) and standard protocol (3 mW/cm2, 30min) in Down syndrome patients with progressive keratoconus
Design
In this concealed parallel RCT, 30 Down patients with a definite bilateral progressive keratoconus will enroll. Based on balanced block randomization, one eye of each patient is selected for accelerated group and the fellow eye is treated by the standard protocol as the control. The surgeries are done under anesthesia. Parents complete the consent form prior to the procedure. Corvis and Pentacam tests are performed before and one-year after cross-linking.
Settings and conduct
This study is performed at Noor Eye Hospital, Tehran. To concealment, randomization will be done by another one not the surgeon. The patients, parents and optometrist (examiner of outcomes) will be masked to the treatment group of each eyes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definite Down syndrome, Progressive keratoconus, age 10-30 years and minimum cooperation to imaging and examinations.
Exclusion criteria: concurrent intellectual disability such as autism and klinefelter, history of ophthalmic surgery and corneal pathology such as pterygium.
Intervention groups
Intervention group: The one eye of bilateral case will undergo 10-min protocol of cross-linking, randomly.
Control group: The fellow eye of patient will undergo 30-min method of cross-linking.
All procedures will be performed under general anesthesia in operation room.
Main outcome variables
one-year change in corneal biomechanics; one-year change in corneal topographic indices.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100706004333N3
Registration date:2018-07-10, 1397/04/19
Registration timing:prospective
Last update:2018-07-10, 1397/04/19
Update count:0
Registration date
2018-07-10, 1397/04/19
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
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Accelerated and Standard Corneal Cross-linking in Down Syndrome keratoconic patients: A Randomized Clinical Trial
Public title
comparison of 10- and 30-min CXL in Down patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
definite Down syndrome
Progressive keratoconus
age 10-30 years old
minimum cooperation for imaging
Exclusion criteria:
concurrent intellectual disability such as Autism or Klinefelter
History of ophthalmic surgery
corneal pathology such as Pterygium
Age
From 10 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Two eyes of bilateral keratoconic patients
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization by a person other than surgeon
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients and parents will be masked to treatment group (10- and 30-min CXL) of each eyes.
The optometrist who do the pre- and post-tests will be masked to treatment group (10- and 30-min CXL) of each eyes of patients.
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
Intervention group: 10-minutes cross-linking will be perform for one eye of bilateral keratoconic patients under general anesthesia.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1621
Fax
+98 21 8865 1514
Email
soheilaasgari@gmail.com
Web page address
http://www.norc.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Hassan Hashemi, MD
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
soheilaasgari@gmail.com
Web page address
http://www.norc.ac.ir/
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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Position
no member of review board
Latest degree
Ph.D.
Other areas of specialty/work
Ophthalmic Research
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
soheilaasgari@gmail.com
Web page address
http://www.norc.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Hassan Hashemi, MD
Position
full professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
research@norc.ac.ir
Web page address
http://www.norc.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Noor Eye Hospital
Full name of responsible person
Soheila Asgari
Position
no member of review board
Latest degree
Ph.D.
Other areas of specialty/work
Ophthalmic Research
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8865 1515
Fax
+98 21 8865 1514
Email
soheilaasgari@gmail.com
Web page address
http://www.norc.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Based on demand, only the required part of data is shared unidentified.
When the data will become available and for how long
3 months after publication
To whom data/document is available
Researcher of Medical and Biomedical engineering Universtiy
Under which criteria data/document could be used
With adhere to the author's copyright of the current project
From where data/document is obtainable
Sending an academic email to Dr. Soheila Asgari "soheilaasgari@gmail.com"
What processes are involved for a request to access data/document
It is possible to send a request via academic email address, 3 months after publication. The personal profile, data and purpose of study should be mentioned. The ethical approval of study should be sent via email.