Comparison of accelerated and conventional corneal collagen cross-linking for progressive keratoconus in visual acuity, topographic indices, endothelial cell density in one year follow up
purpose of study is Comparison of accelerated and conventional corneal collagen cross-linking for progressive keratoconus in visual acuity, topographic indices, endothelial cell density in one year follow up. study design is interventional, randomized, double blind. samples are between keratoconus patients. if any have other ocular disease or any medical or surgical intervention previous and duration of study or involvement corneal ulcer or any corneal scar are excluded. sample size estimate 72 eyes that are divided equal between two groups. after soaking of cornea with riboflavin irradiated by ultraviolet A. power of Ultraviolet A in one group is used 3 mW/cm2 in30 minute and in other group 18 mW/cm2 in 5 minute. full examination and measuring corrected and uncorrected visual acuity and performing topography, orbscan, specularmicroscopy are done before and 3, 6, 12 month after treatment in all of patients. thereafter all results are compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080723537N1
Registration date:2015-09-06, 1394/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-06, 1394/06/15
Registrant information
Name
Seyyed Mohsen Moosazadeh
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 2477
Email address
moosazadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz,Jundishapur University of Medical Sciences
Expected recruitment start date
2015-08-16, 1394/05/25
Expected recruitment end date
2016-08-14, 1395/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of accelerated and conventional corneal collagen cross-linking for progressive keratoconus in visual acuity, topographic indices, endothelial cell density in one year follow up
Public title
comparison of accelerated and conventional collagen cross-linking in treatment of keratoconus patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: keratoconus diagnosis based topography and orbscan.
exclusion criteria: other ocular diseases; corneal ulcer involvement; surgical intervention duraton study; any corneal scar
Age
From 12 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ahvaz, Jundishapur University of Medical Sciences
Street address
Ground floor، Vice chancellor for research and technology، Jundishapur University of Medical Sciences، Golestan Avenue، Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AJUMS.REC.1394.245
Health conditions studied
1
Description of health condition studied
Keratoconus
ICD-10 code
H18.6
ICD-10 code description
Keratoconus
Primary outcomes
1
Description
uncorrected distance visual acuity
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
E chart
2
Description
corrected distance visual acuity
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
E chart
3
Description
endothelial cell density
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
specularmicroscopy
4
Description
endothelial cell hexagunality
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
specularmicroscopy
5
Description
coefficient of variation
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
specularmicroscopy
6
Description
spherical equivalent
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
autorefractometer
7
Description
thinnest point of cornea
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
orb scan
8
Description
k value in flat meridian
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
orb scan
9
Description
k value in steep meridian
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
orb scan
10
Description
Kmax
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
orb scan
11
Description
keratometry astigmatism value(Kast)
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
orb scan
12
Description
Surface Asymmetry Index (SAI)
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
topography tomy
13
Description
Surcface Regularity Index ( SRI )
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
topography tomy
14
Description
Keratoconus index (KCI)
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
topography tomy
15
Description
Keratoconus predication index (KPI)
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
topography tomy
16
Description
Keratoconus severity index (KSI)
Timepoint
pre-intervention، 3، 6 and 12 month after intervention
Method of measurement
topography tomy
Secondary outcomes
empty
Intervention groups
1
Description
conventional corneal cross-linking: soaking cornea with riboflavin0.1% in 30 minutes then irradiated cornea through ultraviolet A 3 mW/cm2 in 30 minute.
Category
Treatment - Surgery
2
Description
accelerated corneal collagen cross-linking: soaking cornea with riboflavin 0.1% in 30 minutes then irradiated cornea through ultraviolet A 18 mW/cm2 in 5 minute
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyyed Mohsen Moosazadeh M.D
Street address
Eye Ward، Imam Khomeini Hospital، Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz, Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki M.D
Street address
Ground floor، Vice chancellor for research and technology، Jundishapur University of Medical Sciences، Golestan Avenue، Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?