| CTRI Number |
CTRI/2022/01/039643 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Accuracy Validation Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring Eye Pressure using two different Instruments |
|
Scientific Title of Study
|
Comparison of Transpalpebral Easyton Tonometer with Goldmann Appalanation Tonometer in Persons with Glaucoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVidhya Raja S |
| Designation |
Consultant Glaucoma Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 1 Anna Nagar
Madurai 625020
Tamil Nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914524356105 |
| Email |
s.vidya@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVidhya Raja S |
| Designation |
Consultant Glaucoma Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 1 Anna Nagar
Madurai 625020
Tamil Nadu
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914524356105 |
| Email |
s.vidya@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
DrVidhya Raja S |
| Designation |
Consultant Glaucoma Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 1 Anna Nagar
Madurai 625020
Tamil Nadu
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914524356105 |
| Email |
s.vidya@aravind.org |
|
|
Source of Monetary or Material Support
|
| AUROLAB
No 1 Sivagangai Main Road
Veerapanjan
Madurai 625020
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
AUROLAB |
| Address |
No 1 Sivagangai Main Road
Veerapanjan
Madurai 625020
Tamil Nadu
India |
| Type of Sponsor |
Other [Ophthalmic consumables manufacturing unit govern by Trust] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ELAMED |
ELAMED
Building 16
Trubezhnaya street
Ryazan
Russia 390000 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVidhya Raja S |
Aravind Eye Hospital |
No1 Anna Nagar
Madurai 625020
Madurai
TAMIL NADU |
914524356100
914524356105
s.vidya@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with Primary Open Angle Glaucoma, Primary Angle Closure Disease, Pseudo exfoliation Glaucoma, Pigmentary Glaucoma, Normal Tension Glaucoma, Juvenile Glaucoma, Ocular Hypertension and Glaucoma suspects |
|
| ExclusionCriteria |
| Details |
1) Evident scleral and/or conjunctival pathology
2) Presence of transmissible infections/conjunctivitis/keratitis/blepharitis
3) Presence of lid abnormalities such as chalazia, entropion, ectropion, exposure keratitis
4) Presence of corneal diseases precluding GAT, corneal edema, bullous keratopathy and corneal scars
5) Debilitated patients and those with difficulty in neck posture maintenance, cervical spondylitis
6) Inflammatory eye diseases uveitis, significant diabetic retinopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evidence of the accuracy and agreement of IOP measured using EASYTON transpalpebral tonometry in comparsion with the GAT and also the possibility of finding an alternative to GAT especially in screening patients for glaucoma in the community and general ophthalmology clinics |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Submission of the findings in a peer reviewed journal |
12 months |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glaucoma
is the second leading cause of blindness worldwide.
Asians represent 47% of those with glaucoma and 87% of those with angle
closure glaucoma. To the best of our knowledge, till date, elevated
intraocular pressure (IOP) is the only modifiable risk factor. Also, lowering
the IOP is the only proven method of halting disease progression. Hence,
accurate tonometry is indispensable in the diagnosis and management of
glaucoma.
Goldmann applanation tonometer (GAT) considered as the reference standard
tonometry for measuring IOP, has its own limitations. Despite its accuracy,
there are some known disadvantages of GAT. The IOP readings are affected by
central corneal thickness (CCT) and corneal pathologies, the need for use of
local anesthesia and the risk of transmissible infections as the prism needs
to be in contact with cornea. Therefore, exploring alternative methods have
always been a point of interest. This propelled us to assess the validity of
the Easyton tonometer, which is a new version of transpalpebral tonometry.
Therefore, exploring alternative methods have always been a point of
interest. This propelled us to assess the validity of the Easyton tonometer,
which is a new version of transpalpebral tonometry compared with GAT. The
possible outcome of the study will to find an effective alternative to GAT,
especially in screening patients for glaucoma in the community and general
ophthalmology clinics.
|
|