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Biomechanical characteristics changes with Ocular Response Analyzer in keratoconic eyes after Intrastromal corneal Ring segment (keraring ) implantation.

Protocol summary

Summary
use of intra stromal corneal ring in patient with clear cornea that unable to use glass or hard contact lens or because irrigularity and high abrasion,glass can not improve visual acuity.so intra stromal corneal ring is one of methods can improve irrigularity of cornea,decreased asthigmatism,improvment of visual acuity,delay of corneal transplantaion.this method newly Take into consideration and few previous studies was surveyed.goal of this study is survey of biomechanical karactristic cornea after 6 months from placement of intra stromal corneal ring,in preoperation survey evaluate refractive error,the best visual acuity.topography performed with pentacam.size ,thickness and number of rings adjusted based on refractory error,thickness of cornea and keraring nomograghy with Manufacturer.two biomechanical factors such as Corneal Hysteresis (CH) و Corneal Resistance Factor (CRF) assess with Ocular Response Analyzer preoperation,1month,6month post operation,necessary information recordin related form pre-post operation,then information analize with spss 17

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071510143N2
Registration date: 2013-08-31, 1392/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-31, 1392/06/09
Registrant information
Name
Tahmineh Aryan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 8124
Email address
afshin_lotfi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-19, 1392/05/28
Expected recruitment end date
2013-10-20, 1392/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Biomechanical characteristics changes with Ocular Response Analyzer in keratoconic eyes after Intrastromal corneal Ring segment (keraring ) implantation.
Public title
Biomechanical characteristics changes with Ocular Response Analyzer in keratoconic eyes after Intrastromal corneal Ring segment (keraring ) implantation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-patient satisfaction 2-Progressive deterioration of vision so that the patient dose not necessary visual function with contact lenses or glasses for the daily work 3-patient with clear central cornea 4-cornea thickness equal or more than 450 micrometer in 5 sites incision 5-absent of local or diffuse autoimmune disease exclusion criteria: 1-post refractive surgery ectasia 2-previous corneal transplantation 3- corneal opacity 4- cornea thickness lesser than 450 micrometer in 5 sites incision 5- local or diffuse autoimmune disease
Age
From 21 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
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,avenue golgasht,tabriz
City
tabriz
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
9284

Health conditions studied

1

Description of health condition studied
keratocunos
ICD-10 code
H18.6
ICD-10 code description
keratocunos

Primary outcomes

1

Description
Corneal Hysteresis (CH) و Corneal Resistance Factor (CRF)
Timepoint
preoperation,1&6 month post operation
Method of measurement
Ocular Response Analyzer (ORA)

Secondary outcomes

1

Description
visual acuity
Timepoint
preoperation,1&6 month post operation
Method of measurement
snellen chart

Intervention groups

1

Description
clinical trial study, The design of this study is cross over,two biomechanical factors such as Corneal Hysteresis (CH) و Corneal Resistance Factor (CRF) assess after placement of keraring intra stromal cornea ring in keratoconic patient at 1th & 6th month
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Nikukari Eye Hospital
Full name of responsible person
dr afshin lotfi
Street address
Nikukai Hospital, Abbasi St.,tabriz
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medica lSciences(chancellor for research
Full name of responsible person
Vice chancellor for research /dr seyed kazem shokori
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht St.,tabriz
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medica lSciences(chancellor for research
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
dr mohammad vashagh
Position
MB, resident of Ophthalmology
Other areas of specialty/work
Street address
Nikukari Eye Hospital, Abbasi St.,tabriz
City
tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
mveshagh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr afshin lotfi
Position
Ophthalmologist
Other areas of specialty/work
Street address
Nikukari hospital, Abbasi St.,tabriz
City
tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
afshin_lotfi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr mohammad veshagh
Position
MB, resident of Ophthalmology
Other areas of specialty/work
Street address
Nikukari Eye Hospital, Abbasi St.,tabriz
City
tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
mveshagh@gmail.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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