CTRI Number |
CTRI/2023/09/057217 [Registered on: 01/09/2023] Trial Registered Prospectively |
Last Modified On: |
28/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
ANALYTICAL OBSERVATIONAL PROSPECTIVE STUDY |
Study Design |
Other |
Public Title of Study
|
Clinical profile, visual outcome and quality of life in patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy |
Scientific Title of Study
|
Clinical Profile, Visual Outcome and quality of Life in patients undergoing Pan retinal photocoagulation for Proliferative diabetic Retinopathy |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Meghavi Pandya |
Designation |
Junior resident |
Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
Address |
Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Wardha MAHARASHTRA 442001 India |
Phone |
09408771706 |
Fax |
|
Email |
meghavi17@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Shashank banait |
Designation |
Associate Professor |
Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
Address |
Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Wardha MAHARASHTRA 442001 India |
Phone |
9822226124 |
Fax |
|
Email |
shashankbanait@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Meghavi Pandya |
Designation |
Junior resident |
Affiliation |
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha |
Address |
Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Wardha MAHARASHTRA 442001 India |
Phone |
09408771706 |
Fax |
|
Email |
meghavi17@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Jawaharlal Nehru Medical College SAWANGI |
Address |
SAWANGI WARDHA |
Type of Sponsor |
Private medical college |
|
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 MEGHAVI PANDYA |
Jawaharlal Nehru Medical College |
Department of Ophthalmology,
Acharya Vinobabhave Rural Hospital
Sawangi(Meghe) Wardha MAHARASHTRA |
09408771706
meghavi17@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: H358||Other specified retinal disorders, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Patients with diabetes type 1 or diabetes type 2 having Proliferative diabetic retinopathy.
Patients of age 40 years or above
Patients willing to undergo and fit for pan retinal Photocoagulation Procedure.
Patients consenting for follow up visits at 1 month, 6 month and 1 year.
|
|
ExclusionCriteria |
Details |
Patients with non-proliferative diabetic retinopathy (NPDR)/ severe NPDR.
Patients receiving additional ocular intervention such as intravitreal injection or cataract surgery.
Patients with gestational diabetes.
Patients with corneal opacities deleteriously affecting their visual acuity.
Patient below age of 40 years.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Prevalence of proliferative diabetic retinopathy is more in diabetics of 40 years age or above as compared to diabetics with age below 40 years
Improvement in quality of life & visual outcome of patients undergoing pan retinal photocoagulation for proliferative diabetic retinopathy is much greater compared other treatment methods
|
1 month 6 months and 1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="57" Sample Size from India="57"
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)
|
08/09/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Diabetes
mellitus (D.M.) is a major medical problem throughout the world. The prevalence of diabetes in India is 2.4% in the rural population and 4.0-11.6% in the urban population. It is estimated that 20% of the current
global diabetic population resides in the Southeast Asia region.
Worldwide 150 million
cases are currently
diagnosed, predicted to be
doubled by 2025. India is committed to an initiative of Vision 2020: The Right to Sight, thus having targets
for ophthalmic infrastructure in its tenth five-year plan. Diabetes mellitus (D.M.) is a significant cause of avoidable blindness in both developing and developed countries.
Patients with diabetic retinopathy (DR) are 25 times more likely to become
blind than non-diabetics. In the
natural course, approximately 50% of patients with very severe N.P.D.R. (non-proliferative diabetic
retinopathy) progress to PDR (proliferative diabetic retinopathy) within
1 year. Panretinal photocoagulation (P.R.P.) is the preferred form of
treatment for proliferative diabetic retinopathy (P.D.R.). The DRS
found that PRP (pan retinal photocoagulation) prevented severe visual loss by over 50% at 2 and 4 years of followup. However,
many studies have been done on pan-retinal photocoagulation for proliferative diabetic retinopathy. The aim of this study is to observe the clinical
profile, visual outcome and quality of life in patients undergoing pan-retinal photocoagulation for proliferative diabetic retinopathy. |