| CTRI Number |
CTRI/2024/09/073340 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non-Interventional, Non-Randomized |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-Interventional Study of Over the Eyelid Tonometry to measure the Intraocular pressure of eye. |
|
Scientific Title of Study
|
An Open-label, Non-Interventional, Non-Randomized, Observational, Single Arm Study to evaluate
Accuracy and Safety of Over the Eyelid Tonometry OET Accuway , in measuring Intraocular Pressure
compared to Goldmann Applanation Tonometry (GAT) and Air-Puff Tonometry (APT). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OISN/ELTM-01/PILOT-P/067 Version 1.0 dated 18 March 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun Ahuja |
| Designation |
Principal Investigator |
| Affiliation |
Sadhu-Kamal Eye Hospital |
| Address |
Room No 104, 105, 1st Floor, Ophthalmic department, Building No. 2, Navjivan Society, Lamington Road, Mumbai Central-400008.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820118832 |
| Fax |
|
| Email |
dr_arjunahuja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Lande |
| Designation |
Founder-CEO, OKO iCare Solutions pvt ltd |
| Affiliation |
OKO iCare Solutions pvt ltd |
| Address |
OKO iCare Solutions pvt ltd, 171-A, Kharbi Road, New Diamond Nagar, Nagpur, Maharashtra 440009.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
8087645687 |
| Fax |
|
| Email |
nehalande89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Lande |
| Designation |
Founder-CEO, OKO iCare Solutions pvt ltd |
| Affiliation |
OKO iCare Solutions pvt ltd |
| Address |
OKO iCare Solutions pvt ltd, 171-A, Kharbi Road, New Diamond Nagar, Nagpur, Maharashtra 440009.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
8087645687 |
| Fax |
|
| Email |
nehalande89@gmail.com |
|
|
Source of Monetary or Material Support
|
| OKO iCare solutions pvt ltd, 171-A, Kharbi Road, New Diamond Nagar, Nagpur, Maharashtra, India, 440009. |
|
|
Primary Sponsor
|
| Name |
OKO iCare Solutions pvt ltd |
| Address |
171-A, Kharbi Road, New Diamond Nagar, Nagpur, Maharashtra, India, 440009 |
| Type of Sponsor |
Other [Medical Device Manufacturing Company-indian] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Ostwal |
Dhanashri Netralaya |
1st Floor, Ophthalmic department, Near Shani Mandir, Dag Borkhedi, Hinganghat, Dist. Wardha, Maharashtra, India, 442301.
Wardha
MAHARASHTRA |
9326810200
drsanjayostwal@yahoo.in |
| Dr Arjun Ahuja |
Sadhu-Kamal Eye Hospital |
Room Number 104, 105, 1st Floor, Ophthalmic department, Building Number 2, Navjivan Society, Lamington Road, Mumbai Central, India, 400008.
Mumbai
MAHARASHTRA |
9820118832
dr_arjunahuja@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of Aayush Hospital |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H400||Glaucoma suspect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Air-Puff Tonometry (APT) |
Air puff tonometers (APT) are non-contact devices that applanate the cornea by a puff of air and measure IOP by the time required to flatten a given area of the cornea. As the pressure of the air pulse directed to the cornea increases to deform the cornea, the corneal surface behaves like a plane mirror, reflecting light to the
detector |
| Comparator Agent |
Goldmann
Applanation Tonometry (GAT) |
The Goldmann applanation tonometer (GAT) is currently the most popular tonometer available. It consists of a double prism mounted on a standard slit lamp. The GAT represents the gold standard for IOP measurement and is used in all major randomized glaucoma clinical trials. With the GAT, the force required to flatten, or applanate, a constant area of the cornea is measured and related to the IOP using the Imbert–Fick principle. The GAT uses an applanation diameter of 3.06 mm and is performed with the patient seated at
the slit lamp. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Normal IOP:
1. Male or Female: Age ≥ 18 years Male or Female
2. Healthy volunteers with no history of corneal disease, ocular hypertension, or glaucoma age and gender match control, non Glaucoma cases.
3. Participants having ≤10 mmHg IOP also included.
4. Willing and able to provide informed consent for participation in the study.
5. Ability to undergo intraocular pressure (IOP) measurements using Air puff tonometry, over-the eyelid tonometry, and Goldmann tonometry
Abnormal IOP:
1. Male or Female: Age ≥ 18 years
2. Suspected or recently diagnosed Glaucoma cases.
3. Participants having ≤10 mmHg IOP also included.
4. Willing and able to provide informed consent for participation in the study.
5. Ability to undergo intraocular pressure (IOP) measurements using Air puff tonometry, over-the eyelid tonometry, and Goldmann tonometry
|
|
| ExclusionCriteria |
| Details |
1. Participants under the age of 18.
2. Inability to provide informed consent
3. Known contraindications to any of the tonometry techniques (Air puff tonometry, over-the-eyelid tonometry, Goldmann tonometry), have significant corneal abnormalities, acute eye infections or have a history of ocular surgery within the past 6 months.
4. Chronic conjunctivitis, cornea pathology, including keratitis, keratotomy, cornea dimness, after penetrating keratoplasty, keratoprosthesis, high degree of ametropia, astigmatism, Edema, Injury to the eyelid, upper lid pathology (inflammatory diseases, scars, eyelid deformation).
5. Expressed sclera and/or conjunctiva pathology in the measuring area, Viral infections, allergic reactions, dry eye syndrome, Post corneal surgery, laser refractive correction of the eyesight.
6. Significant corneal abnormalities and acute eye infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accuracy of IOP measurements as determined by the mean difference between the novel
over-the-eyelid tonometry device and the GAT and APT devices |
At Baseline Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra-device & inter-device variability in IOP measurements.
Patient comfort & preference for the different tonometry methods.
Incidence of adverse events associated with each tonometry method.
Safety & tolerability of the over-the-eyelid tonometry device as assessed by the
presence of any adverse events or participant-reported discomfort.
User acceptability of the over-the-eyelid tonometry device as determined by participant
satisfaction & ease of use.
|
At Baseline Visit |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/11/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Clinical Study Report
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - For research purpose
- By what mechanism will data be made available?
Response (Others) - At the CTRI site
- For how long will this data be available start date provided 30-03-2025 and end date provided 29-03-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The prospective, multicenter, open-label, single-arm study will adopt a design aiming to evaluate various intraocular pressure (IOP) measurement techniques among patients with different ocular conditions, including glaucoma suspects, or those with normal intraocular pressure. A total of 102 selected subjects, encompassing 204 eyes, will be enrolled in this comparative study, with recruitment occurring over a 2-month period, comprising those with normal (IOP 11-22 mm of Hg) and abnormal IOP (Low IOP less than 10mm of Hg and High IOP greater than 22mm of Hg). Air puff tonometry (APT) will be administered first, followed by over-the-eyelid tonometry OET Accuway, and finally Goldmann applanation tonometry (GAT) in both eyes to prevent applanation-induced lowering of IOP. For OET Accuway a mean of three readings will be recorded. A 10-minute break will be set between each IOP measurement to minimize after-measurement fluctuations in the IOP. Prior to any study-related procedures, informed consent will be diligently obtained from each participant, adhering strictly to ethical guidelines. Baseline assessments, inclusive of comprehensive medical history, ocular examination, and initial IOP measurements employing all three tonometry techniques (OET [Accuway], APT, GAT), will be meticulously performed on the same day. Data collection will employ a standardized form, capturing demographic details such as age, gender, and IOP measurements obtained from all three tonometers. The study arm will be single, focusing on OET (Accuway)/GAT/APT within subjects. The observational/diagnostic IPs will include Over-the-eyelid tonometry OET (Accuway) as the observational diagnostic device and Goldmann tonometry (GAT) and Air puff tonometry (APT) as gold standard diagnostic devices. The expected study timeline is set at 3 months, with a 2-month enrolment period. |