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CTRI Number  CTRI/2018/04/013173 [Registered on: 11/04/2018] Trial Registered Retrospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Laser Delivery System]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This study is to evaluate the anesthetic pain and discomfort during retinal photocoagulation. 
Scientific Title of Study   Pre-emptive sub-conjunctival anaesthesia for Pan Retinal Photocoagulation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
06/2012  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rameez N Hussain 
Designation  Consultant Ophthalmologist 
Affiliation  Giridhar Eye Institute 
Address  Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020

Ernakulam
KERALA
682020
India 
Phone  9444527891  
Fax    
Email  dr.rameezhussain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rameez N Hussain 
Designation  Consultant Ophthalmologist 
Affiliation  Giridhar Eye Institute 
Address  Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020


KERALA
682020
India 
Phone  9444527891  
Fax    
Email  dr.rameezhussain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rameez N Hussain 
Designation  Consultant Ophthalmologist 
Affiliation  Giridhar Eye Institute 
Address  Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020


KERALA
682020
India 
Phone  9444527891  
Fax    
Email  dr.rameezhussain@gmail.com  
 
Source of Monetary or Material Support  
Giridhar Eye Institute Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020 
 
Primary Sponsor  
Name  Giridhar Eye Institute 
Address  Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020 
Type of Sponsor  Research institution and hospital 
 
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 Rameez N Hussain  Giridhar Eye Institute  Dept of Vitreo Retina 28 2576 Ponneth Temple Road Kadavanthra Cochin 682 020
Ernakulam
KERALA 
9444527891
04844000584
dr.rameezhussain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Giridhar Eye Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lignocaine 0.5 ml.  After a test dose lignocaine, patient will be given subconjunctival lignocaine 0.5 ml in one eye and sham injection in the other eye. Subsequently Pan Retinal Photocoagulation is performed.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Proliferative Diabetic Retinopathy patients posted for Pan Retinal Photocoagulation in both eyes. 
 
ExclusionCriteria 
Details  Recent history (less than one month) of ocular surgery in any one eye.
Allergy to Lignocaine 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of Pain.  Incidence of Pain. 
 
Secondary Outcome  
Outcome  TimePoints 
Time duration of the procedure
Severity of pain
Quadrants of retina treated uninterrupted 
8 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2012 
Date of Study Completion (India) 13/01/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Introductin
Laser photocoagulation or retinopexy is a common form of treatment used to manage a large variety of retinal disorders such as occlusive retinovascular diseases and peripheral retinal breaks. This is typically perormed using a laser delivery system mounted to a biomicriscope or an indirect ophthalmoscope, with the aid of a contact lens or condensing lens respectively, the laser beam is focused onto the patient’s retina to create a visible white retinal burn that will eventually result in a chorioretinal scar, which treats the disorder. Pan Retinal Photocoagulation is an effective treatment in reducing severe visual loss in patients with proliferative diabetic retinopathy. The diabetic retinopathy study recommended that treatment consists of 800-1600 argon laser burns of 500 mm size to the peripheral retina in a scatter fasion. However, previous studies have shown that PRP is a painful procedure for most patients. The pain is caused by the stimulation of pain receptors in the sclera when a retinal laser burn is induced, and this has been reported to occur in up to 73% of patients. Therefore, to reduce patient suffering during PRP some pain-relieving procedures are necessary when performing PRP. There are several options to reduce pain associated with PRP performed on an outpatient basis. Retrobulbar anaesthesia, peribulbar anaesthesia and sub tenon anaesthesia are effective pain relieving procedures but are invasive for patients with potential complications.

Aim of the Study is to evaluate the efficacy of sub conjunctival anesthesia for pain and discomfort during retinal photocoagulation and to assess whether it helps to reduce time duratin of the procedure. 

Materials and Methods: This is a single-center, prospective, randomized controlled trial. 
Total of 30 patients (60 eyes).
30 eyes in one group

Consent will be taken. After a test dose of lignocaine, patient will be given subconjunctival lignocaine 0.5 ml in one eye and sham injection in the other eye using random allocation software. PRP will be performed in both eyes.

A questionnaire to describe comfort level, presence, intensity and type of pain will be given to the patients at the end of the procedure. This will be recorded using a numerical pain assisting procedure. Laser parameters that were recorded included power settings, number of burns, and method of laser delivery. 

Results will be statistically analysed.
 
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