Our aim in this study is to evaluate the clinical and morphological corneal changes after intrastromal corneal ring segment (Keraring) implantation in patients with keratoconus. In a unicentral clinical trial, 30 keratoconus patients from both genders referring to clinics of Nikoukari eye Hospital Tabriz, Iran, will be involved for intrastromal corneal ring segment implantation. The key inclusion criteria are intolerance to hard contact lenses; and to have keratometry less than 70 diopters. The main inclusion criteria are to suffer from any local or diffused autoimmune disease. Topography would be accomplished by Pentacam device; size, thickness and number of needed rings would be determined based on keratometry, corneal thickness and Keraring tomogram. All the participants will undergo intrastromal corneal ring segment; Keraring (Mediphacos, Belo Horizonte) implantation which is made up of polymethylen acrylate. A radial incision using a diamond knife between two marked arcs will be performed. Mentioned rings then, will be placed through the canal between the arcs in the depth of 80%. Evaluation of the patients in terms of visual acuity and keratometry will be performed before the surgery, 5, 20, 45 days and 3 months after the surgery. Evaluation with Pentacam will be done at least 3 months after the surgery. Then the obtained data will be statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106026695N1
Registration date:2013-05-19, 1392/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Mohammad Mirzaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2171
Email address
mirzaiem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-08, 1391/12/18
Expected recruitment end date
2013-09-09, 1392/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and Morphological Corneal Changes After Intrastromal Corneal Ring Segment (Keraring) Implantation In Keratoconus Patients
Public title
Clinical Effectiveness of A Surgical Method In Keratoconus Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (intolerance to hard contact lenses; to have corneal thickness equal to or more than 400 micrometers in the area of Keraring placing; to have keratometry less than 70 diopters)
Exclusion criteria: (to have any local or diffused autoimmune disease)
Age
From 18 years old to 55 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
91176
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 the intervention, 5, 20, 45 days and 3 months after the intervention
Method of measurement
Using Snellen chart
2
Description
Refractive power of cornea
Timepoint
Before the intervention, 5, 20, 45 days and 3 months after the intervention
Method of measurement
Using keratometer
3
Description
Topography
Timepoint
Before the intervention, 3 months after the intervention
Method of measurement
Using Pentacam device
Secondary outcomes
empty
Intervention groups
1
Description
All the participants will undergo intrastromal corneal ring segment; Keraring (Mediphacos, Belo Horizonte) implantation which is made up of polymethylen acrylate. A radial incision using a diamond knife between two marked arcs will be performed. Mentioned rings then, will be placed through the canal between the arcs in the depth of 80%.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Nikukari Hospital
Full name of responsible person
Amin Najafi
Street address
Clinics ward, Nikukari Hospital, Abbasi St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht Avenue, Daneshgah Square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Amin Najafi
Position
Ophthalmology resident, student
Other areas of specialty/work
Street address
Nikukari Hospital, Abbasi St.
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
Dr_Najafi84@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Mirzai
Position
Associate professor, Ophthalmologist
Other areas of specialty/work
Street address
Nikukari Hospital, Abbasi St.
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
Dr_Najafi84@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General Physician
Other areas of specialty/work
Street address
Emam Reza Hospital, Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)