| CTRI Number |
CTRI/2012/01/002317 [Registered on: 03/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective evaluation |
| Study Design |
Other |
|
Public Title of Study
|
Eye and Diabetic Disease |
|
Scientific Title of Study
|
A Prospective evaluation of the eye and systemic conditions in self reported diabetics in a tertiary eye institute located in Eastern India |
| Trial Acronym |
LEAD Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTaraprasad Das |
| Designation |
Director(PI) |
| Affiliation |
L.V.Prasad Eye Institute |
| Address |
L.V.Prasad Eye Institute,
Patia,
Bhubaneswar-751024,Orissa
Khordha
ORISSA
751024
India |
| Phone |
916743987201 |
| Fax |
916743987130 |
| Email |
tpd@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTaraprasad Das |
| Designation |
Director(PI) |
| Affiliation |
L.V.Prasad Eye Institute |
| Address |
L.V.Prasad Eye Institute,
Patia,
Bhubaneswar-751024,Orissa
Khordha
ORISSA
751024
India |
| Phone |
916743987201 |
| Fax |
916743987130 |
| Email |
tpd@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrTaraprasad Das |
| Designation |
Director(PI) |
| Affiliation |
L.V.Prasad Eye Institute |
| Address |
L.V.Prasad Eye Institute,
Patia,
Bhubaneswar-751024,Orissa
Khordha
ORISSA
751024
India |
| Phone |
916743987201 |
| Fax |
916743987130 |
| Email |
tpd@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
LVPrasad Eye Institute |
| Address |
L.V.Prasad Eye Institute,
Patia,
Bhubaneswar-751024,orissa |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrTaraprasad Das |
L.V.Prasad Eye Institute |
L.V.Prasad Eye Institute,
Patia
Bhubaneswar-751024,Orissa
Khordha
ORISSA |
916743987201
916743987130
tpd@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hyderabad Eye Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who are known Diabetic are enrolled in the study, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Known Type-2 Diabetis mellitus
2.willing to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1.Non-Diabetic
2.Not willing to sign informed consent form |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.presence in level of Diabetic retinopathy
2.co-existing systemic conditions other than diabetic condition
3.Knowledge,attitude and practice in patients with DM.
4.Quality of life in patients with Diabetic retinopathy. |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the step 1 was the general examination at the entry point of the study.This included a detailed eye examination,anthropometry,blood biochemistry and the Knowledge,Attitude and Practice(KAP) level.The eye examination included a detailed personal and family history,visual acuity measurement using illuminated ETDRS chart placed at 4 meter distance,refraction,Goldmann applanation pressure,gonioscopy when necessary,dilated fundus examination and color fundus photography using 3 Nethra fundus camera.The blood biochemistry included lipid profile,renal profile,HbA1C and hemoglobin level.KAP questionnaire was administered to all the study patients. The step II was the specific diabetic retinopathy(DR) related investigation.It was done in patients who were detected to have any stage of diabetic retinopathy clinically.This included fluorescein angiography and optical coherence tomography.The National Eye Institute Vision Function Questionnaire 25(NEI VFQ 25) was administered to all study patients who entered the stage II of the study. The step III was the specific treatment of patients with Diabetic Retinopathy.This essentially consisted of one of the three or combination of retinal laser,intravitreal anti-vascular endothelial growth factor(VEGF) injection and vitrectomy. |