| CTRI Number |
CTRI/2019/06/019753 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
17/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How limitation of daily activities impacts quality of life in patients with moderate and severe glaucoma |
|
Scientific Title of Study
|
Impact of activity limitation on quality of life in moderate and severe primary open angle glaucoma patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shifali Narang |
| Designation |
Junior Resident |
| Affiliation |
GMCH sector 32 Chandigarh |
| Address |
Government medical college and hospital, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9779210092 |
| Fax |
|
| Email |
shifalinarang16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Ophthalmology, Government medical college and hospital, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121588 |
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shifali Narang |
| Designation |
Junior Resident |
| Affiliation |
GMCH sector 32 Chandigarh |
| Address |
Government medical college and hospital, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9779210092 |
| Fax |
|
| Email |
shifalinarang16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Shifali Narang |
Government Medical College and Hospital |
Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9779210092
shifalinarang16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acting as controls |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with moderate and severe open angle glaucoma in both eyes and on medical therapy/had trabeculectomy at least 3 months prior or cataract surgery 6 months prior |
|
| ExclusionCriteria |
| Details |
patients with mild glaucoma/with mobility or cognitive or hearing impairment or psychiatric diseases,immunosuppression and/or other concurrent ocular diseases |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study impact of activity limitation on quality of life in moderate and severe open angle glaucoma patients |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate and compare Glaucoma Associated Quality of Life 15, Glaucoma Activity Limitation 9 and Viswanathan questionnaires in moderate and severe glaucoma patients |
At presentation |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
20/06/2019 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Glaucoma causes significant activity limitation of routine day to day activities in patients, thus affecting their quality of life. Through this study we aim to assess how quality of life is affected in moderate to severe glaucoma patients, using various questionnaires. |