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CTRI Number  CTRI/2018/10/016218 [Registered on: 31/10/2018] Trial Registered Prospectively
Last Modified On: 02/09/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   What makes the patients with glaucoma come to the hospital ? 
Scientific Title of Study   A prospective study to evaluate the reasons for hospital visit among patients with primary glaucoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Department of Glaucoma (Room No 21), Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone    
Fax    
Email  oannamalai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Department of Glaucoma (Room No 21), Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone    
Fax    
Email  oannamalai@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Annamalai O 
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital 
Address  Department of Glaucoma (Room No 21), Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone    
Fax    
Email  oannamalai@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry - 605007. 
 
Primary Sponsor  
Name  Aravind Eye Hospital 
Address  Cuddalore main road, Thavalakuppam, Pondicherry - 605007 
Type of Sponsor  Research institution and hospital 
 
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 
Annamalai O  Aravind Eye Hospital  Department of Glaucoma, Room No 21, Cuddalore main road, Thavalakuppam, Pondicherry - 605007.
Pondicherry
PONDICHERRY 
8098888247

oannamalai@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee - Aravind Eye hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Newly confirmed patients with primary glaucoma of any type 
 
ExclusionCriteria 
Details  1. Patient already on medication for suspected glaucoma
2. Glaucoma suspects
3. Review patients
4. Ocular hypertension
5. Patients with secondary glaucoma
6. Patients who are not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the reasons from glaucoma patients for their visit to glaucoma clinic.  This is a cross sectional study. The reasons for presentation will be assessed at the time of first presentation to the glaucoma clinic at Aravind Eye Hospital, Pondicherry. 
 
Secondary Outcome  
Outcome  TimePoints 
1. We would also determine the relationship between seeking care and the following factors:
a.Age
b.Rural / Urban
c.Gender
d.Education
e.Socio-economic status
f.Type of glaucoma
g.Severity of glaucoma

2. We would like to look into the potential issues in maintaining follow up (e.g. distance, time, companion, etc).
 
This is a cross sectional study. Data will be collected at the time of first presentation to the glaucoma clinic.

Statistical analysis will be performed after complete enrollment of the adequate sample size. 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   03/11/2018 
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)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Glaucoma is chronic, progressive asymptomatic optic neuropathy due to a variety of ocular conditions which lead to damage of the optic nerve with permanent visual loss and eventual blindness. Intraocular pressure is the only modifiable risk factor. It is usually unnoticed until advanced visual field loss is present or central field is damaged. To date, there is no neuro-regenerative therapy and visual loss is permanent. Therefore early diagnosis is imperative.

Various population studies have shown that about one half of all persons with manifest glaucoma in a given population are unaware that they have the disease. Normal tension glaucoma was found to be four times as common in patients identified through population screening compared to self-selected patients suggesting that special efforts like glaucoma screening are necessary to detect manifest glaucoma at an earlier stage than it currently is.

Hypothesis

The evaluation and discovery of the reasons for seeking eye care for glaucoma are important as this might help us better understand the human factors and develop new and better strategies to capture a larger section of the population.

 
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