| CTRI Number |
CTRI/2022/11/047800 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
15/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the quality of life in glaucoma patients with the help of interviews |
|
Scientific Title of Study
|
Exploring the quality of life in persons living with Glaucoma - A Qualitative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Evangeline Golda |
| Designation |
PG Student |
| Affiliation |
Acchutha Eye care and Institute of Optometry, Erode |
| Address |
Acchutha Eye care and Institute of Optometry, Erode
Erode
TAMIL NADU
638009
India |
| Phone |
7539936138 |
| Fax |
|
| Email |
evangelinevictor99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Saranya SB |
| Designation |
Principal |
| Affiliation |
Acchutha Eye care and Institute of Optometry, Erode |
| Address |
Acchutha Eye care and Institute of Optometry, Erode
Erode
TAMIL NADU
638009
India |
| Phone |
9940455322 |
| Fax |
|
| Email |
ssaranbala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balasubramaniam C |
| Designation |
Professor |
| Affiliation |
Acchutha Eye care and Institute of Optometry, Erode |
| Address |
Acchutha Eye care and Institute of Optometry, Erode
Erode
TAMIL NADU
638009
India |
| Phone |
9940455422 |
| Fax |
|
| Email |
acchuthaeyecare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acchutha Eye care and Institute of Optometry, Erode |
|
|
Primary Sponsor
|
| Name |
Acchutha Eye care and Institute of Optometry Erode |
| Address |
Acchutha Eye care and Institute of Optometry, Erode |
| Type of Sponsor |
Other [Optometry Institution] |
|
|
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 |
| Evangeline Golda |
Acchutha Eye Care |
Acchutha Eye care and Institute of Optometry, Erode
Erode
TAMIL NADU |
7539936138
evangelinevictor99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Erode Cancer Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Eyes with glaucoma (All types of primary open-angle, chronic angle-closure )
Stage: Visual field loss involving at least two quadrants in the Humphery visual field analyser |
|
| ExclusionCriteria |
| Details |
Not willing participants
Associated disease like cataract
Below 30 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study aims to understand the day-to-day life of glaucoma patients through a qualitative
study (interview guide). The data collected will be analysed using thematic analysis.
Thematic Analysis (Luborsky MR 1994) will be done with the following steps:
1. Familiarize with the data
2. Coding or highlighting
3. Themes generation
4. Defining and renaming the themes |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Glaucoma is a chronic, progressive optic neuropathy associated with a group of ocular conditions that damage the optic nerve head leading to visual field loss as damage progresses. The
important part is a rise in intraocular pressure (IOP) that can lead to irreversible vision loss. Glaucoma is also known as the "sneak thief of sight" (Tandon R., 2019).Once loss of
visual field is at an advanced stage, a point is reached at which loss of sight significantly impacts a glaucoma patient’s vision-related Quality of Life and mental condition. Quality of life (QOL) is an individual’s assessment of their position in life in the environment and value systems in which they live concerning their aim, hope, norms, and activity. It is a
wide-ranging concept affected in a complex way by the person’s physical health, cerebral state, position of independence, social connections, particular beliefs and connections to their society. The Quality of life in cases of glaucoma can be affected in several ways, similar as due to reduced visual field and reduced visual perceptivity, economic issues similar as the cost of drugs, health centre visits, and mental goods on the Quality of life, including fear of blindness, anxiety, and depression. (Suresh Kumar et al., 2018). The significance of illness in glaucoma cases provides a theoretical base for perfecting the vision-related Quality of life in glaucoma cases according to cognitive mental interventions (Zhang Q et al., 2022).
|