| 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
|
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Kankanady, Mangalore, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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 |