| CTRI Number |
CTRI/2018/12/016529 [Registered on: 05/12/2018] Trial Registered Prospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation Of Details Of Patients Less Than 40 Years Of Age With Raised Pressure In The Eye |
|
Scientific Title of Study
|
Clinical And Demographic Profile Of Patients Less Than 40 Years Of Age Presenting To The Glaucoma Services At A Tertiary Care Eye Hospital In South India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parab Aditi Pradeep |
| Designation |
DNB Resident |
| Affiliation |
Aravind Eye Hospital & Postgraduate Institute Of Ophthalmology |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8655846440 |
| Fax |
|
| Email |
aditiparab4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Kavitha |
| Designation |
Senior Consultant, Glaucoma Services |
| Affiliation |
Aravind Eye Hospital & Postgraduate Institute Of Ophthalmology |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
|
| Fax |
|
| Email |
skavitha.shree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parab Aditi Pradeep |
| Designation |
DNB Resident |
| Affiliation |
Aravind Eye Hospital & Postgraduate Institute Of Ophthalmology |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8655846440 |
| Fax |
|
| Email |
aditiparab4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Parab Aditi Pradeep |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry |
| Type of Sponsor |
Other [Self] |
|
|
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 Parab Aditi Pradeep |
Aravind Eye Hospital & Postgraduate Institute Of Ophthalmology |
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pincode- 605007
Pondicherry
PONDICHERRY |
8655846440
aditiparab4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in the age group of 5 years to 39 years referred to the glaucoma services for the first time from the general clinic of Aravind Eye Hospital or from elsewhere.
2) Known glaucoma patients, in the age group of 5 years to 39 years, presenting to glaucoma department for review visits.
|
|
| ExclusionCriteria |
| Details |
1) Patients who are not willing or not able to give an informed written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of various clinical types of glaucoma in age group less than 40 years of age. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To determine the reasons for referral of patients less than 40 years of age to glaucoma services.
2) The association between a positive family history and glaucoma.
3) The impact of demographic profile of the patients in relation to their diagnosis of different types of glaucoma.
4) The impact of socioeconomic status of the patients in relation to their diagnosis of different types of glaucoma.
|
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
10/12/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Cross-Sectional study to be done with the primary objective of studying the prevalence of various types of glaucoma in patients less than 40 years age and assessing the reasons for referral of these patients. Secondary objectives are to assess the impact of demographic profile of the patients in relation to their diagnosis and to assess the association of family history and glaucoma in the study population. We will also try to find out if there is any impact of education and socioeconomic status on staging of glaucoma. On reviewing literature, we found that there is scarcity of studies related to clinical and demographic profile of patients with glaucoma in less than 40 years age group. Hence, we aim to know the prevalence rates of various clinical types of glaucoma in patients less than 40 years age group which in turn can help in developing various glaucoma screening protocols for the under 40 age group.
|