Long term efficacy of cornea collagen cross-linking (CXL) in Pellucid Marginal Degeneration (PMD) in improving Topographic findings, Visual Acuity (VA) and Refraction
This study is designed to determine whether CXL is helpful for patients diagnosed with PMD in long term or not
Design
A quasi-experimental study, without randomization, not blinded, to be conducted on 40 patients
Settings and conduct
Patients enrolled in this study have underwent CXL in Isfahan Feyz hospital prior to 2015. The study is conducted in Isfahan. The intervention in this study is already done ergo there was no need for randomization and blinding.
This study aims to compare keratometric and visual factors of patients before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients that underwent CXL due to mild to moderate PMD before 2015 in Feyz hospital located in Isfahan. Exclusion criteria: inaccessible patient; history of other ophthalmologic surgeries; history of herpetic keratitis
prior use of hard contact lens.
Intervention groups
There is only one intervention group in this study, patients that underwent CXL before 2015
Main outcome variables
Topographic findings, Refraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130306012724N4
Registration date:2020-06-04, 1399/03/15
Registration timing:prospective
Last update:2020-06-04, 1399/03/15
Update count:0
Registration date
2020-06-04, 1399/03/15
Registrant information
Name
Alireza Peyman
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3445 2031
Email address
peyman@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Long term efficacy of cornea collagen cross-linking (CXL) in Pellucid Marginal Degeneration (PMD) in improving Topographic findings, Visual Acuity (VA) and Refraction
Public title
Long term efficacy of cornea collagen cross-linking (CXL) in Pellucid Marginal Degeneration (PMD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that underwent CXL due to mild to moderate PMD before 2015 in Feyz hospital located in Isfahan
Exclusion criteria:
History of herpetic keratitis
Prior use of hard contact lens
History of other ophthalmologic surgeries
Inaccessible patient
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)
Not randomized
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 Science
Street address
Hezar jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.MUI.MED.REC.1399.104
Health conditions studied
1
Description of health condition studied
PMD, Pellucid Marginal Degeneration
ICD-10 code
H18.711-71
ICD-10 code description
Pellucid Marginal Degeneration
Primary outcomes
1
Description
Uncorrected Visual Acuity (UCVA)
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Snellen chart
2
Description
Best Corrected Visual Acuity (BCVA)
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Snellen chart
3
Description
K1
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
4
Description
K2
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
5
Description
K max
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
6
Description
Thinnest
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
7
Description
Q value
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
8
Description
Sphere
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
autorefractometry
9
Description
Cylinder
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
autorefractometry
10
Description
ISV
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
11
Description
IVA
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
12
Description
IHA
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
Pentacam topography
13
Description
D
Timepoint
Before intervention, Present time (after at least 5 years from the intervention)
Method of measurement
autorefractometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients that underwent CXL. After total manual debridement of the cornea epithelium, the cornea impregnated with riboflavin using the riboflavin 0.1% + Dextran 20% drops instilled every 2 minutes for 30 minutes; the yellowish glare on slit lamp examination in anterior chamber was utilized to confirm adequate riboflavin penetration to the tissue. The cornea irradiated with ultraviolet A light at 3mW/cm2 and 5.4 j for 30 minutes with a UV light source.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz hospital
Full name of responsible person
Dr. Alireza Peyman
Street address
Modarres St., Ghods Sq., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
feiz@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Research dept., Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7653
Email
research@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
Dr. Alireza Peyman
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz hospital, Modares St.,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
peyman@med.mui.ac.ir
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, Modares St.,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
peyman@med.mui.ac.ir
Person responsible for updating data
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, Modares St.,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
peyman@med.mui.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
All researchers who are interested
Under which criteria data/document could be used
Selected researchers
From where data/document is obtainable
Contact principal investigator
What processes are involved for a request to access data/document
Maximum one month after contacting the principal investigator