FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College SAWANGI 
Address  SAWANGI WARDHA 
Type of Sponsor  Private medical college 
 
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 
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  
Status 
Not Applicable 
 
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.

 
Close