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Investigating the association between clinical and ocular characteristics with the outcomes of corneal collagen cross-linking (CXL) in patients with keratoconus (KC)

Protocol summary

Study aim
Investigating the association between clinical and ocular characteristics with the outcomes of corneal collagen cross-linking (CXL) in patients with keratoconus (KC)
Design
Clinical trial without control group and only
Settings and conduct
This study was a prospective cohort study that enrolls all possible cases (85 eyes) of surgical naive KC who were candidate for CXL, were visited in Feiz Eye Hospital affiliated to Isfahan University of medical sciences, Isfahan, Iran. At the surgical day, demographic information including sex, age and smoking, and familial history of kc, clinical diagnosis including visual acuity, intraocular pressure, biomicroscope slit lamp, ophthalmoscopy indiameter, pentacon imaging and laboratory tests including surface markers for tear biomarkers were collected. Patients were visited from one day and three days after surgery for possible complications including corneal opacity, refractive back disorder.The next day, three days, 90 days and one year after the intervention, clinical and laboratory cases and possible complications were evaluated and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: keratoconus patients who are newly candidates for corneal collagen cross-linking. Patient satisfaction. Non-Inclusion criteria: other corneal diseases. pregnancy, and breastfeeding period. Patients who have any of the following concomitant ocular diseases: diabetic macular edema, age-related macular degeneration.
Intervention groups
A total of 85 patients with keratoconus were evaluated for visual acuity, intraocular pressure, and tear biomarkers prior to surgery for collagen cornea linkages. Three days later, 90 days later and one year later, these cases were measured and recorded.
Main outcome variables
Visual acuity, intraocular pressure, surface of tear biomarkers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131229015975N4
Registration date: 2019-05-02, 1398/02/12
Registration timing: retrospective

Last update: 2019-05-02, 1398/02/12
Update count: 0
Registration date
2019-05-02, 1398/02/12
Registrant information
Name
Mohsen Pourazizi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 1385
Email address
m.pourazizi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-01-20, 1397/10/30
Scientific title
Investigating the association between clinical and ocular characteristics with the outcomes of corneal collagen cross-linking (CXL) in patients with keratoconus (KC)
Public title
Investigating the association between clinical and ocular characteristics with the outcomes of corneal collagen cross-linking (CXL)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction keratoconus patients who are newly candidates for corneal collagen cross-linking
Exclusion criteria:
Patients who have any of the following concomitant ocular diseases: diabetic macular edema, age-related macular degeneration. other corneal diseases pregnancy, and breastfeeding period
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 85
Actual sample size reached: 85
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
IR.MUI.RES.1396.3.545

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
Before surgery and six months after surgery.
Method of measurement
Snellen chart

2

Description
Corneal power
Timepoint
Before surgery and six months after surgery.
Method of measurement
Pentacam imaging

Secondary outcomes

1

Description
Levels of tear biomarkers
Timepoint
Before surgery and six months after surgery.
Method of measurement
The lab using ELISA TEAR IL6 and Tear TNF-α tests

Intervention groups

1

Description
Intervention group: 85 patients with keratoconus, underwent corneal cross-collagen surgery to improve the patient's vision and prevent disease progression. Visual acuity, intraocular pressure, and tear biomarkers were measured by pentacet imaging and ELISA TEAR IL6 and Tear TNF-α tests. The time intervals before surgery and six months later, were evaluated.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Feyz Hospital in Isfahan
Full name of responsible person
Alireza Peyman
Street address
Quds Square.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
drpeyman@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Faraj Zadegan
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar Jerib Avenue.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Pourazizi
Position
M.D.
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
m.pourazizi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Peyman
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz Hospital
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Fax
Email
drpeyman@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Pourazizi
Position
M.D.
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
m.pourazizi@yahoo.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
All information is available after being unidentifiable and two years after the publication of the article.
When the data will become available and for how long
two years after the publication of the article.
To whom data/document is available
Assistants and Ophthalmologists
Under which criteria data/document could be used
To compare the available information with information that is available at another time by another researcher.
From where data/document is obtainable
Send an application to drpeyman@hotmail.com and get permission from the research vice president of Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send an application to drpeyman@hotmail.com and get permission from the research vice president of Isfahan University of Medical Sciences.
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