| CTRI Number |
CTRI/2023/03/050252 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A prospective study to compare two surgical techniques, conventional and minimally invasive, for an eye muscle, the inferior oblique, in squint patients |
|
Scientific Title of Study
|
Minimally Invasive Strabismus Surgery versus the conventional surgical technique for the Inferior Oblique muscle |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tushit Dhar |
| Designation |
Postgraduate Resident |
| Affiliation |
Maulana Azad Medical College and associated Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi
B-215, Pocket 2
Kendriya Vihar II
Sector 82, Noida, District GB Nagar
Uttar Pradesh- 201304
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
tushitdhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhash Dadeya |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Guru Nanak Eye Centre |
| Address |
Room No. 114
OPD Block
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
dadeya868@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhash Dadeya |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Guru Nanak Eye Centre |
| Address |
Room No. 114
OPD Block
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
dadeya868@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre, New Delhi |
|
|
Primary Sponsor
|
| Name |
Tushit Dhar |
| Address |
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi- 110002 |
| Type of Sponsor |
Other [Principal Investigator (Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Subhash Dadeya |
Room No. 114
OPD Block
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi-110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tushit Dhar |
Guru Nanak Eye Centre |
Room Number 207
Squint, Orthoptics and Pleoptics Clinic
Department of Ophthalmology
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg
New Delhi-110002
Central
DELHI |
9971194231
tushitdhar@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 Hospitals (Lok Nayak, GIPMER and Guru Nanak Eye Centre) |
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: H502||Vertical strabismus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional perilimbal surgical technique |
Exposure and reinsertion of the inferior oblique muscle via large conjunctival incision 8mm beyond the limbus, and assessment of postoperative results over 6 weeks |
| Intervention |
Minimally Invasive Strabismus Surgery |
Exposure and reinsertion of the inferior oblique muscle via small radial cuts and keyhole incisions in the conjunctiva, close to the muscle insertion, and assessment of postoperative results over 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with primary or secondary, unilateral or bilateral inferior oblique muscle overaction
Inferior oblique overaction defined as hypertropia of 20 prism diopters or more in adduction |
|
| ExclusionCriteria |
| Details |
Patients with previous surgery for the inferior oblique muscle
Patients requiring other vertical muscle surgery in addition to inferior oblique surgery
Patients with pre-existing bleeding diatheses |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conjunctival injection (4-step standard reference scale), chemosis (4-grade scale), periorbital edema (4-grade scale) |
First postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conjunctival injection (4-step standard reference scale), chemosis (4-grade scale), periorbital edema (4-grade scale) |
1 week, 6 weeks |
| Degree of inferior oblique overaction in prism diopters |
First postoperative day, 1 week, 6 weeks |
| Ocular alignment in nine gaze photography |
First postoperative day, 1 week, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2023 |
| Date of Study Completion (India) |
01/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in the Japanese journal of ophthalmology |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, single blind, parallel group, single centre trial comparing the cosmetic and surgical outcomes of Minimally Invasive Strabismus Surgery and the conventional perilimbal surgical technique in 40 squint patients with inferior oblique muscle overaction that will be conducted at a tertiary care eye hospital in Delhi, India. The primary outcome measures will be conjunctival injection, chemosis and periorbital edema on the first postoperative day. The secondary outcomes will be conjunctival injection, chemosis and periorbital edema at 1 week and 6 weeks; the degree of inferior oblique overaction on the first postoperative day, at 1 week and 6 weeks; and ocular alignment on the first postoperative day, at 1 week and 6 weeks. |