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CTRI Number  CTRI/2014/12/005288 [Registered on: 15/12/2014] Trial Registered Retrospectively
Last Modified On: 12/12/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study that compares eye pressure measurements taken by two instruments, Icare tonometer and Goldmann applanation tonometer in normal children. 
Scientific Title of Study   Comparison of intraocular pressure with Icare tonometer and applanation tonometer in paediatric age group  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunayana Bhat MBBS MS Ophthal  
Designation  Assistant Professor 
Affiliation  Department of Ophthalmology 
Address  Father Muller Medical College, Kankanady, Mangalore, Karnataka.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9611102754  
Fax    
Email  chanyn9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meghana Patil MBBS PG student in MS Ophthal  
Designation  Postgraduate student 
Affiliation  Department of Ophthalmology 
Address  Father Muller Medical College, Kankanady, Mangalore,

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7204351640  
Fax    
Email  drmeghana14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunayana Bhat MBBS MS Ophthal  
Designation  Assistant Professor 
Affiliation  Department of Ophthalmology 
Address  Father Muller Medical College, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9611102754  
Fax    
Email  chanyn9@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Kankanady, Mangalore, Karnataka, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunayana Bhat  Father Muller Medical College  Department of Ophthalmology, kankanady, Mangalore, Karnataka, India.
Dakshina Kannada
KARNATAKA 
9611102754

chanyn9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Intraocular pressure of Normal children in the age group of 7-14 years will studied 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Goldmann applanation tonometer  Goldmann applanation tonometer is a contact tonometer used to measure intraocular pressure and is the current gold standard method 
Intervention  Icare tonometer  Icare tonometer is a rebound tonometer used to measure intra ocular pressure 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  - Informed consent by parents/guardians
- Normal children aged 7-14 years presenting for ophthalmology evaluations to the department clinic during the study period.
- Those children who can cooperate with measurement of IOP by Goldmann applanation tonometer and Icare tonometer.  
 
ExclusionCriteria 
Details  1. children with a history of glaucoma, ocular surface disorders like allergic conjunctivitis, infections, corneal scarring, eye trauma, and previous ocular surgeries.
2.Uncooperative children and those who were squeezing the lids during the Icare readings were also excluded.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
comparison of the iop measured between two instruments  Point measure -Single measurement by two instruments with around 5 minutes gap on same day 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation and agreement between the two instrument readings  Point measure -Single measurement by two instruments with around 5 minutes gap on same day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Accurate measurement of intraocular pressure (IOP) is a vital component in the screening, diagnosis and management of paediatric glaucoma. Goldmann applanation tonometry (GAT) has been the gold standard method for IOP measurement in adults, but many new alternative methods and devices have been developed in the last few years.Newer methods for IOP measurement are necessitated by certain limitations of GAT, which include its invasiveness, need for topical anaesthesia, slit-lamp mounting with sitting posture, and disinfection of tonometer head after each use,  requirement of an experienced technician, variability of readings depending on corneal material properties, curvature and thickness, and inaccuracy in post-refractive surgery eyes.

The invasiveness of GAT is a major limiting factor in the pediatric population, especially in younger children, who do not cooperate and resist eye examination. A tonometer that produces less sensations on eye contact may be more acceptable to children, who are usually anxious and uncooperative when touched in their eyes by GAT. 

The Icare tonometer® is a rebound tonometer (RBT) that operates on the principle of measuring the motion parameters of a probe that bounces back after making contact with the eye, with higher IOPs resulting in faster rebounds. The impact of the sensor against central cornea is minimal and six readings are obtained in rapid succession without eliciting the blink reflex. Icare is a portable device, doesn’t require topical anesthesia, can be hand-held few millimetres away from the eye, all of which may be less frightening to children.  The probe in icare tonometer has a disposable tip that obviates need for disinfection, but can also be potentially reused after disinfection with less chances of crossifection. In addition, icare can be handled effectively even by less experienced tonometrists. Previous studies in adults have shown that IOP values measured with Icare tonometry (ICT) have a positive bias compared to values of GAT, but ICT can be a reliable method due to its good correlation with GAT, both in healthy and glaucomatous eyes. 

 In the pediatric age group, ICT is a comfortable, accurate and reproducible method with high rates of successful IOP measurement and has been observed to reduce the need for anesthesia.  ICT has been reported to be one of the preferred methods for IOP measurement in children less than ten-years in real life clinical settings.  

The purpose of this study was to compare the agreement in IOP readings taken with Goldmann applanation tonometer and ICare® rebound tonometer in a normal paediatric cohort. 

Null Hypothesis:

IOP measured by Icare tonometer will be not significantly different from that measured by the comparator gold standard Goldmann applanation tonometer

IOP measured by Icare tonometer will have good correlation (Pearsons correlation) and agreement (Bland-Altmann method) with Goldmann applanation tonometer

 
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