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Comparison between accelerated and conventional methods of Cornea collagen crosslinking in prognosis of keratoconus patients, referred to Feiz hospital in 2013

Protocol summary

Summary
Keratoconus is a progressive disorder that usually presents in patients during their twenties. The cornea gets thin and changes shape. Today a new method is suggested in treatment of keratoconus, named cross-linking; this method, which can be performed in a usual 30-minute surgery or a newer 5-minute surgery, is fast and relatively pain free and has led to remarkably good results. Up to this date few studies have been done on the usual and accelerated cross-linking methods, comparison between them and their prognosis. The aim of this study is to compare the prognosis of patients with keratoconus between usual and accelerated methods of cross-linking procedure. The study is conducted as randomized clinical trial, including two groups of intervention. Forthy patients with keratconus, matching the inclusion criteria, will be enrolled and randomly divided into two groups. Baseline values of variables, including visual acuity, refractory errors, keratometeric and topographic indexes will be collected from both groups. One group will undergo a routine 30-minute procedure while the other is treated with a faster, 5-minute, procedure according to the established protocols of cross linking surgery. Same variables will be measured after 6 months and the data will be measured against its base line value and the data acquired from the other group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013040912960N1
Registration date: 2013-05-11, 1392/02/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-11, 1392/02/21
Registrant information
Name
Ali Rahimi
Name of organization / entity
Isfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1338 6836
Email address
alirahimi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of medical sciences department of research and technology
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between accelerated and conventional methods of Cornea collagen crosslinking in prognosis of keratoconus patients, referred to Feiz hospital in 2013
Public title
Comparison between accelerated and conventional methods of Cornea collagen crosslinking in keratoconus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: documented keratoconus patients who had refractive error higher than 2 diopters and were willing to participate in the study. Exclusion criteria: patients with poor compliance, who do not follow the post-operation orders precisely and confound the results, such as avoiding to take their medicine or not taking them correctly; patients who are affected with endophthalmitis or any other ophthalmic diseases after surgery; patients with systemic diseases such as collagen vascular disease.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square
City
Isfahan
Postal code
Approval date
2011-11-17, 1390/08/26
Ethics committee reference number
391326

Health conditions studied

1

Description of health condition studied
keratoconus
ICD-10 code
H18.6
ICD-10 code description
conical cornea

Primary outcomes

1

Description
Visual acuity
Timepoint
Before intervention, 6 months after intervention
Method of measurement
Snelen chart

2

Description
Keratometeric evaluation
Timepoint
Before intervention, 6 months after intervention
Method of measurement
Pentacam anterior SimK

3

Description
Topographic evaluation
Timepoint
Before intervention, 6 months after intervention
Method of measurement
Pentacam Scheimpflug imagery

4

Description
Refractory error
Timepoint
Before intervention, 6 months after intervention
Method of measurement
Auto refractive

Secondary outcomes

empty

Intervention groups

1

Description
Usual 30-minute cross link surgery of keratoconus , using riboflavin and florescent light to stabilize corneal collagen and prevent progressive destruction of cornea
Category
Treatment - Surgery

2

Description
Accelerated 5-minute cross link surgery of keratoconus , using riboflavin and uniform florescent light to stabilize corneal collagen and prevent progressive destruction of cornea
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Alireza Peiman M.D.
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Research and technology department
Full name of responsible person
Peiman Adibi M. D.
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square
City
ISfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Research and technology department
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
Isfahan University of Medical Sciences
Full name of responsible person
Alireza Peiman M.D.
Position
Assistant Professor, Department of Ophthalmology, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Feiz hospital , Qods square
City
Isfahan
Postal code
Phone
+98 31 1338 6836
Fax
Email
rahimi_ali1359@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Alireza Peiman M.D.
Position
Assistant Professor, Department of Ophthalmology, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Feiz hospital , Qods square
City
Isfahan
Postal code
Phone
+98 31 1338 6836
Fax
Email
rahimi_ali1359@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali Rahimi, M. D.
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
+98 31 1338 6836
Fax
Email
rahimi_ali1359@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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