| 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
|
|
|
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
|
|
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, |
|
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Intervention / Comparator Agent
|
|
|
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. |