| CTRI Number |
CTRI/2023/04/052040 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Out come of Mullers muscle conjunctival resection surgery and small incision surgery for mild old age related ptosis |
|
Scientific Title of Study
|
Comparison of Mullers muscle conjunctival resection (MMCR)surgery and Small incision surgery for acquired mild involutional ptosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SANJAY SHARMA |
| Designation |
POST DIPLOMA DNB RESIDENT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
OCULOPLASTY DEPARTMENT
SANKARA EYE HOSPITAL
SIVANANDHAPURAM
COIMBATORE
TAMIL NADU
641035
India
Coimbatore
TAMIL NADU
641035
India |
| Phone |
6361178030 |
| Fax |
|
| Email |
sssanjay058@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRABHUSHANKER M |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
RETINA DEPARTMENT
SANKARA EYE HOSPITAL
SIVANANDHAPURAM
COIMBATORE
TAMIL NADU
641035
India
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9443186568 |
| Fax |
|
| Email |
drprabhushanker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANJAY SHARMA |
| Designation |
POST DIPLOMA DNB RESIDENT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
SITE NO 8
SAKTHI NAGAR
VILLANKURUCHI ROAD
SARAVANAMPATTI
VINAYAGAPURAM
COIMBATORE
TAMILNADU
641035
INDIA
Coimbatore
TAMIL NADU
641035
India |
| Phone |
6361178030 |
| Fax |
|
| Email |
sssanjay058@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SANKARA EYE HOSPITAL |
| Address |
SANKARA EYE HOSPITAL
SATHY ROAD
SIVANANDHAPURAM
COIMBATORE
TAMIL NADU
641035 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 SANJAY SHARMA |
SANKARA EYE HOSPITAL |
DEPARTMENT OF OCULOPLASTY
SANKARA EYE HOSPITAL
SATHY ROAD
SIVANANDAPURAM
COIMBATORE
TAMILNADU
641035
Coimbatore
TAMIL NADU |
6361178030
sssanjay058@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sankara Eye Hospital,Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H024||Ptosis of eyelid, (3) ICD-10 Condition: H024||Ptosis of eyelid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IMPROVEMENT IN PTOSIS AND LID SHAPE |
IMPROVEMENT IN
MARGINAL REFLEX DISTANCE-1(MRD1)
PALPEBRAL FISSURE HEIGHT
LID CONTOUR
POST OPERATIVE PAIN
WILL BE COMPARED AFTER THE EACH PROCEDURE |
| Intervention |
MULLERS MUSCLE CONJUNCTIVAL RESECTION SURGERY |
POSTERIOR APPROACH FOR EYELID PTOSIS CORRECTION SPARING THE TARSUS. |
| Intervention |
SMALL INCISION PTOSIS SURGERY |
IT IS AN ANTERIOR APPROACH FOR THE CORRECTION OF MILD PTOSIS INVOLVING TARSAL PLATE |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with acquired mild involutional ptosis
|
|
| ExclusionCriteria |
| Details |
Prior surgery on the same eyelid.
Concomitant eyelid or brow surgery at the time of ptosis repair.
Congenital, traumatic, neurogenic, mechanical or myogenic ptosis.
HIV associated blepharoptosis.
History of conjunctival glaucoma filtering blebs.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
IMPROVEMENT IN MARGINAL REFLEX DISTANCE-1(MRD1)
POST OPERATIVE PAIN
PALPEBRAL FISSURE HEIGHT
LID CONTOUR |
POST OPERATIVE DAY 1
POST OPERATIVE DAY 30
POST OPERATIVE DAY 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CHANE IN SHAPE OF THE PTOTIC EYELID BEFORE AND AFTER SURGERY
|
POST OPERATIVE DAY 1
POST OPERATIVE DAY 29
POST OPERATIVE DAY 89 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/05/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY TITLE: COMPARISON OF MULLERS MUSCLE CONJUNCTIVAL RESECTION SURGERY AND SMALL INCISION SURGERY IN MILD ACQUIRED INVOLUTIONAL PTOSIS.
§Involutional ptosis occurs due to
the natural ageing.
Aponeurotic defects and
disinsertion of the levator
aponeurosis are responsible for acquired involutional ptosis.
MULLER’S
MUSCLE CONJUNCTIVAL RESECTION IS Posterior eyelid ptosis repair
technique AND SPARES TARSUS
small incision is an external approach
|