| CTRI Number |
CTRI/2023/03/050763 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Barriers in glaucoma medication adherence for children in South India |
|
Scientific Title of Study
|
Caregiver reported barriers to medication adherence, follow up and access to eye care centers in pediatric patients visiting the glaucoma clinic of a tertiary eye hospital in South India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Sanjay Wagh |
| Designation |
Primary Resident Doctor |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room no.21, Glaucoma clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9769118336 |
| Fax |
|
| Email |
akshay.sanjay@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Upadhyaya |
| Designation |
Medical Consultant Glaucoma Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room no.21, Glaucoma clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Sanjay Wagh |
| Designation |
Primary Resident Doctor |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room no.21, Glaucoma clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9769118336 |
| Fax |
|
| Email |
akshay.sanjay@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Sanjay Wagh |
| Address |
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry-605007, 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 |
| Dr Akshay Sanjay Wagh |
Aravind Eye Hospital |
Room no.20, Glaucoma clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY |
9769118336
akshay.sanjay@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40-H42||Glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Caregivers of less than 18 years Children on anti-glaucoma medications for primary glaucoma, secondary glaucoma, secondary raised IOP due to any pathology
|
|
| ExclusionCriteria |
| Details |
1. Children of caregivers with special needs, developmental delay, and other systemic illnesses.
2. Caregivers who are themselves on treatment with anti-glaucoma drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the main reasons for non-Adherence to medication, follow up and access to eye care among the Caregivers of Paediatric patients visiting glaucoma services. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the reason behind missed or delayed follow-ups and access to the eye care facility. |
One year |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
01/04/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Objectives- To analyze the main reasons for non-Adherence to medication, follow up and access to eye care among the Caregivers of Paediatric patients visiting glaucoma services. Secondary Objectives- To understand the reason behind missed or delayed follow-ups and access to the eye care facility. Hypothesis: We expect a better adherence and compliance to Anti Glaucoma medications in pediatric population as caregivers are involved in the process. |