| CTRI Number |
CTRI/2024/12/078242 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the role of injection mydricaine and topical diclofenac eye drops in maintaining pupillary diameter during surgery |
|
Scientific Title of Study
|
A Prospective randomised controlled study to determine the role of preoperative subconjunctival injection mydricaine and topical diclofenac sodium in maintaining mydriasis in diabetic vitrectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V NIVETHA |
| Designation |
Post Graduate Student |
| Affiliation |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital |
| Address |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi Road, Egmore, India, Chennai 600008
Chennai
TAMIL NADU
600008
India |
| Phone |
8300123772 |
| Fax |
|
| Email |
vethu1303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S HEMAPRIYA |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital |
| Address |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi Road, Egmore, Chennai, India 600008
Chennai
TAMIL NADU
600008
India |
| Phone |
9944846151 |
| Fax |
|
| Email |
hemapriya.siva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V NIVETHA |
| Designation |
Post Graduate Student |
| Affiliation |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital |
| Address |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi Road, Pudupet, Komaleeswaranpet, Egmore, Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
8300123772 |
| Fax |
|
| Email |
vethu1303@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi road, Egmore Chennai, India 600008 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Ophthalmology |
| Address |
Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi Road, Egmore, Chennai, India 600008
|
| Type of Sponsor |
Government 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 V NIVETHA |
Regional Institute of Ophthalmology |
Room NO 301 AND 302, 3RD Floor, Regional Institute of Ophthalmology and Government Ophthalmic Hospital, Rukmani Lakshmipathi Road, Egmore, India, Chennai 600008
Chennai
TAMIL NADU |
8300123772
vethu1303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H334||Traction detachment of retina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adrenaline, Atropine, Lignocaine, cyclopentolate, phenylephrine |
The role of preoperative subconjunctival injection mydricaine 0.5ml once and 1% topical dilcofenac sodium 1 drop 4 times comapred with routine topical tropicamide 1 drop once with common instillation of 1% cyclopentolate 1 drop 4 times and 2.5% phenylephrine 1 drop 2 times given 2 hours prior to surgery to maintain mydriasis during vitrectomy surgery |
| Comparator Agent |
Tropicamide, phenylephrine, cyclopentolate |
The role of preoperative subconjunctival injection mydricaine 0.5ml once and 1% topical dilcofenac sodium 1 drop once 4 times comapred with routine topical tropicamide and phenylephrine 1 drop given with common insttillation of 1% cyclopentolate given 1 drop 4 times and 2.5% phenylephrine 1 drop 2 times given 2 hours prior surgery to maintain mydriasis during vitrectomy surgery. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with advanced diabetic eye disease with
1. Tractional retinal detachment, tractional retinal detachment with vitreous hemorrhage, nonresolving vitreous hemorrhage of minimum 3 months duration, good glycemic control , patients with pupil briskly reacting to light
|
|
| ExclusionCriteria |
| Details |
Patients who had previous vitreoretinal surgery or any intraocular procedure within 6 weeks, visually significant cataract,pregnancy, history of CVA, myocardial infarction within three months, hypertensive patients, CKD patients, patients with pupil abnormalities |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increased and consistent pupillary diameter |
60 minutes of start of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A good pupillary dilatation is essential to perform an effective posterior segment surgery. An alternate to routine topical Tropicamide and Phenylephrine is subconjunctival injection Mydricaine and topical Diclofenac Sodium given 30 minutes prior the procedure to maintain effective mydriasis till the end of 90 minutes estimated vitrectomy procedure. A Castroviejo caliper is used to measure the pre and post surgical pupillary diameter. |