| CTRI Number |
CTRI/2023/07/055772 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Assessment/Trial of Silicon Sling for correction of Senile (age related) Lower Eye Lid Ectropion- A PILOT STUDY. |
|
Scientific Title of Study
|
Evaluation of Silicon Sling for correction of Involutional Lower EyeLid Ectropion - A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Sudhakar |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
536 Pocket 5 Mayur Vihar Delhi 110091
Bahadur shah Zafar Marg, near Delhi Gate, New Delhi
110002
East
DELHI
110091
India |
| Phone |
9810069865 |
| Fax |
|
| Email |
akshi.lhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ruchi Goel |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
T 011, Capital Greens, DLF Motinagar, Karampura, New Delhi
Bahadurshah Zafar Marg, near Delhi Gate, New Delhi 110002
New Delhi
DELHI
110015
India |
| Phone |
9811305645 |
| Fax |
|
| Email |
gruchi1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ruchi Goel |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
T 011, Capital Greens, DLF Motinagar, Karampura, New Delhi
Bahadurshah Zafar Marg, near Delhi Gate, New Delhi 110002
New Delhi
DELHI
110015
India |
| Phone |
9811305645 |
| Fax |
|
| Email |
gruchi1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre
Maharaja Ranjeet Marg, LNJP Colony, Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre,
Maharaja Ranjeet Singh Marg, LNJP Colony,
New Delhi 110002 |
| 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 Akanksha |
Guru Nanak Eye Centre |
Ophthalmology Department
New Delhi
DELHI |
9810069865
AKSHI.LHMC@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Maulana Azad Medical College and associated Hospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
uncontrolled systemic illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pilot study |
EVALUATION OF SILICONE SLING FOR CORRECTION OF INVOLUTIONAL LOWER EYELID ECTROPION- A PILOT STUDY |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patent lacrimal passage
Age > 50 years
Horizontal lower lid laxity > 6mm
|
|
| ExclusionCriteria |
| Details |
Prior lower lid surgery
Patients with dry eye, trichiasis, blepharitis, skin scarring, conjunctivochalasis, meibomitis
Uncontrolled systemic illness
One eyed patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| success rate of the procedure |
4months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| asymmetry in lateral canthal angle. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/08/2023 |
| 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="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
|
In this clinical trial, our target audiance is people of more than 50 yrs of age with lower lid involutional ectropion, presenting to us in the OculoPlasty Clinic with the chief complain of watering (Epiphora) who are patent on syringing/probing. The Ectropion correction is to be done using silicon sling with a followup period of 4 months. |