| CTRI Number |
CTRI/2025/03/082293 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods of Squint surgeries in patients aged more than 12 years with Primary Exotropia |
|
Scientific Title of Study
|
Comparison of Conjunctival- Scleral thickness after Medial Rectus Plication versus Resection |
| 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 Paromita Dutta |
| Designation |
associate professor |
| Affiliation |
guru nanak eye centre |
| Address |
room 101,first floor, squint department,Department of ophthalmology,maulana azad medical college and guru nanak eye centre
Central
DELHI
110002
India |
| Phone |
9873319983 |
| Fax |
|
| Email |
mitad.4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drpalash patni |
| Designation |
PG student |
| Affiliation |
guru nanak eye centre |
| Address |
Department of ophthalmology,maulana azad medical college and guru nanak eye centre
Central
DELHI
110002
India |
| Phone |
8989779900 |
| Fax |
|
| Email |
palashpatni1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drpalash patni |
| Designation |
PG student |
| Affiliation |
guru nanak eye centre |
| Address |
Department of ophthalmology,maulana azad medical college and guru nanak eye centre
Central
DELHI
110002
India |
| Phone |
8989779900 |
| Fax |
|
| Email |
palashpatni1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology,Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
maulana azad medical college |
| Address |
maulana azad medical college and guru nanak eye centre |
| 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 palash patni |
guru nanak eye centre |
room 101,first floor,Squint unit 1A , Guru nanak eye centre,Maulana azad medical college
Central
DELHI |
8989779900
palashpatni1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| maulana azad medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H501||Exotropia, , (2) ICD-10 Condition: H50||Other strabismus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
plication sugery for patients with primary exotropia |
patients will be undergoing medial resection procedures based on the randomization.plication of medial rectus muscle,amount of plication will be done based on calculation from prism bar cover test. the conjunctival-scleral thickness will be compared on anterior segment ocular coherence tomography pre-operatively,1st,3rd and 4th month after surgery. |
| Comparator Agent |
resection surgery for patients with primary exotropia |
patients will be undergoing medial rectus resection procedures based on the ramdomization.resection of medial rectus muscle,amount of resection will be done based on calculation from prism bar cover test. the conjuctival scleral thickness in both the groups will be compared on anterior segment ocular coherence tomography pre operatively, at 1st month,3rd month and 4th month after surgery. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)primary exotropia without oblique overaction
b)Age more than 12 years
c)deviation more than or equal to 30 prism dioptres |
|
| ExclusionCriteria |
| Details |
a)H/o previous strabismus surgery
b)Pre-existing conjunctival scarring
c)Restrictive or paralytic strabismus
d)Inability to position at the ASOCT machine/ e)uncooperative patients.
Patients with nystagmus and patients with anatomic abnormalities (eg, microcornea, anterior segment dysgenesis etc., where scleral spur on ASOCT is unclear)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparision of Conjunctival-scleral (as measured on ASOCT), between plication and resection of medial rectus at 1st,3rd,4th months after surgery.
|
Comparision of Conjunctival-scleral (as measured on ASOCT), between plication and resection of medial rectus at baseline ,1st month,3rd month,4th months after surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Comparision of tear meniscus height (TMH), non invasive tear break-up time (NIBUT) between the groups
b)Difference in Meibography scores between the groups.
c)Difference in Ocular Surface Disease Index (OSDI) scores between the groups.
|
1,3,4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/03/2025 |
| 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)
Modification(s)
|
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
Modification(s)
|
This prospective,randomized,comparative study compares the effect of two surgical procedures i.e. resection and plication in patients with primary exotropia.It would be conducted in guru nanak eye centre,comprising 2 groups of 25 patients per group.The primary outcome is to compare conjunctival-scleral thickness after medical rectus resection vs plication on anterior segment OCT at 1st,3rd and 4th months after surgery. The secondary objective is to compare tear-meniscus height ,non invasive tear break up time,difference in meibography scores and difference in ocular surface disease index(OSDI) between two groups at 1st,3rd and 4th months post surgery. |