FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025441 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 15/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of Quality of life (QOL) in medical and surgical therapies of glaucoma 
Scientific Title of Study   Quality of life in glaucoma patients: Comparison of medical therapy, trabeculectomy and glaucoma drainage device 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Shruti 
Designation  Postgraduate Junior Resident 
Affiliation  GMCH Chandigarh 
Address  Department of Ophthalmology,GMCH 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  07508714156  
Fax    
Email  muralidharanshruti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Kumar 
Designation  Professor and Head Department of Ophthalmology  
Affiliation  GMCH Chandigarh 
Address  Department of Ophthalmology GMCH 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone    
Fax    
Email  drsuresh.kumar.gupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  M Shruti 
Designation  Postgraduate Junior Resident 
Affiliation  GMCH Chandigarh 
Address  Department of Ophthalmology,GMCH 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  07508714156  
Fax    
Email  muralidharanshruti@gmail.com  
 
Source of Monetary or Material Support  
Department of Ophthalmology Government Medical College and Hospital Sector 32 Chandigarh 
 
Primary Sponsor  
Name  Government Medical college and Hospital Chandigarh 
Address  Department of Ophthalmology Government Medical college and Hospital SEctor 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
M Shruti  Government Medical College and Hospital  Department of Ophthalmology GMCH 32 Chandigarh
Chandigarh
CHANDIGARH 		 07508714156

muralidharanshruti@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H409||Unspecified glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • Group I: Patients of moderate and severe glaucoma on medical therapy for a period of 3 months to 1 year.
• Group II: Patients who have undergone glaucoma filtration surgery in the form of trabeculectomy at least 3 months before the study.
• Group III: Patients who have undergone a glaucoma drainage device placement at least 3 months before the study.
 
 
ExclusionCriteria 
Details  Patients with already compromised quality of life owing to physical disability, hearing disability or neuropsychiatric conditions.
Patients who had a trabeculectomy/implant surgery within the 3 months preceding the study period.
Patients with other eye diseases such as visually significant cataract, disorders affecting the retina like diabetic retinopathy, diabetic maculopathy, hypertensive retinopathy, age related macular degeneration (ARMD).
Patients who underwent a cataract surgery in combination with the trabeculectomy in the same sitting (phacotrabeculectomy).
Patients of mild glaucoma or those on monotherapy(receiving single drug therapy)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HRQoL  3 months-1 year 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   31/05/2020 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Glaucoma is one of the leading causes of preventable blindness, a close second to cataract, characterized by progressive optic neuropathy and corresponding visual field loss. Quality of Life (QOL) as perceived by patients with focus on leading a healthy and independent life is an important barometer of the success of any therapeutic modality be it medical or surgical. This assessment guides clinician’s treatment decision, and modifications to home environment facilitating the execution of day to day house-hold activities. To the best of our knowledge, no study from India has compared the QOL in patients with glaucoma on medical therapy and in post trabeculectomy and GDD placements. With this background in mind we decided to conduct this hospital based cross sectional study  to measure and compare the QOL in patients with glaucoma receiving three types of treatment viz medical therapy, trabeculectomy and GDD placement using multiple instruments which include vision-specific NEIVFQ25 and  GQL-15 questionairre enrolling 30 patients of each category.
 
Close