| CTRI Number |
CTRI/2025/01/078972 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Surgery for eye pressure measuring device to be used at home |
|
Scientific Title of Study
|
Enhancing glaucoma management with at-home tonometry: survey of patient and provider preferences
|
| Trial Acronym |
AHTS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology |
| Address |
Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Upadhyaya |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology |
| Address |
Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Swati Upadhyaya |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology |
| Address |
Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry, India. Pin 605007 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Aravind Eye Hospital,
Thavalakuppam,
Cuddalore Main Road, Pondicherry, India. Pin 605007
Pondicherry |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Swati Upadhyaya |
Aravind Eye Hospital, Pondicherry |
Glaucoma clinic, Aravind Eye Hospital,
Thavalakuppam,
Cuddalore main road,
Pondicherry
Pondicherry
PONDICHERRY |
8489810704
swati.dr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AEH-P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Glaucoma specialists with no glaucoma |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H408||Other glaucoma, (3) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients:
1. Adults aged 18 to 75 years diagnosed with glaucoma.
2. Able to provide informed written consent.
3. Presenting to the “Paying†section of Aravind eye care system.
Physicians:
1. Board-certified ophthalmologists or equivalent certification/licensure in ophthalmology.
2. Recognized specialization in glaucoma, demonstrated through fellowship training, a focused practice, or a significant portion of clinical work dedicated to diagnosing and treating glaucoma patients.
3. Minimum of 1 year of clinical experience post-residency or fellowship in treating glaucoma patients.
4. Actively practicing in India and currently treating glaucoma patients.
5. Experience using various diagnostic and therapeutic devices for glaucoma management, including Goldman Applanation Tonometry and the iCare 200.
6. Informed consent to participate in the survey, indicating willingness to share professional opinions and experiences.
|
|
| ExclusionCriteria |
| Details |
Patients:
1. Individuals with cognitive impairments interfering with informed consent.
2. Individuals who are not proficient in Tamil or English, which could impact their ability to understand and respond accurately.
Physicians:
1. Physicians who have potential conflicts of interest, such as financial ties to companies producing glaucoma-related medical devices.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate patient and physician interest in and willingness to use at-home tonometers for IOP measurement.
Survey patients and physicians on preferred device features and design.
|
At the time of administering the survey questionnaire- one time point only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="131"
Sample Size from India="131"
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)
|
01/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We expect high patient and physician interest in at-home tonometry, which may lead to greater interest and availability of at-home tonometry options. |