| CTRI Number |
CTRI/2022/08/044947 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of eye pressures by three instruments in different eye pressure ranges
|
|
Scientific Title of Study
|
Comparability of Intraocular pressure measurement by Non contact, I care and Goldmann applanation tonometry in different IOP ranges |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BADNORE AKANSHA UDAYKUMAR |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
SANKARA EYE HOSPITAL, GUNTUR- VIJAYAWADA EXPRESSWAY,PEDAKAKANI,
GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8329138002 |
| Fax |
|
| Email |
akanshabadnore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MALLESWARI MEDIKONDA |
| Designation |
GLAUCOMA CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
SANKARA EYE HOSPITAL, GUNTUR- VIJAYAWADA EXPRESSWAY,PEDAKAKANI,
GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493714701 |
| Fax |
|
| Email |
malleswari6372@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BADNORE AKANSHA UDAYKUMAR |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
SANKARA EYE HOSPITAL GUNTUR |
| Address |
SANKARA EYE HOSPITAL, GUNTUR- VIJAYAWADA EXPRESSWAY,PEDAKAKANI,
GUNTUR
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8329138002 |
| Fax |
|
| Email |
akanshabadnore@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANKARA EYE HOSPITAL,GUNTUR VIJAYAWADA EXPRESSWAY,PEDAKAKANI, GUNTUR
ANDHRA PRADESH 522509 |
|
|
Primary Sponsor
|
| Name |
BADNORE AKANSHA UDAYKUMAR |
| Address |
SANKARA EYE HOSPITAL,GUNTUR-VIJAYAWADA EXPRESSWAY,PEDAKAKANI,GUNTUR,
522509
ANDHRA PRADESH
INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| AKANSHA UDAYKUMAR BADNORE |
SANKARA EYE HOSPITAL GUNTUR |
SANKARA EYE HOSPITAL,GUNTUR-VIJAYAWADA EXPRESSWAY,PEDAKAKANI,GUNTUR,
522509
Guntur
ANDHRA PRADESH |
8329138002
akanshabadnore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 60 years of age, willing to participate in the study attending Hospital OPD. |
|
| ExclusionCriteria |
| Details |
corneal scarring or opacity,
active corneal or conjunctival infection or wound or epithelial defect,
previous corneal surgery,
congenital corneal abnormalities – microphthalmos, nanophthalmos
high corneal astigmatism (>1.5D),
keratoconus,
blepharospasm
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Intraocular pressure readings of Non contact, I care and Goldmann Applanation tonometer in patients of different IOP ranges |
on the day of presentation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate IOP readings with corrected IOP (IOP after considering central corneal thickness) |
on the day of presentation |
|
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Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "208"
Final Enrollment numbers achieved (India)="208" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2022 |
| Date of Study Completion (India) |
22/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The intra ocular pressure refers to the pressure exerted by intra ocular contents on the coats of the eye ball. Intra ocular pressure represents a fundamental factor of ocular health and disease. For IOP measurement, Goldmann applanation tonometry is considered as a worldwide accepted gold standard so far in clinical practice. Though more accurate it is time consuming and contact based procedure. Also requires local anaesthesia. The main advantage of NCT and I care is that they are easier to use as well as do not require local anaesthesia. Therefore, the purpose of this study is to compare the IOP values measured by NCT, I Care and GAT and evaluate the inter device agreement in different IOP groups(<11,11-21,22-30mmhg).
The study included, patients between 18 to 60 years of age, willing to participate in the study attending Sankara Eye Hospital OPD. We got 208 eyes of 115 patients as the sample size. All patients satisfying the inclusion and exclusion criteria had undergone ophthalmological examination. Further, IOP measurement was performed using an NCT-iCare-GAT sequence. In this study, we obtained the IOP, CCT and Keratometric values from both eyes of each patient. Based on the IOP measured with GAT, all the subjects were divided into three groups. Intraocular pressure readings of Non contact, I care and Goldmann Applanation tonometer were compared in patients of different IOP ranges. while Icare may serve as a viable alternative when GAT is not available, GAT remains the gold standard in IOP assessment.
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