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
|
|
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
|
|
Health Condition / Problems Studied
Modification(s)
|
|
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. |