| CTRI Number |
CTRI/2026/02/104004 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [randomised control trail] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effectiveness of amblyopia management after surgery of retinal detachment |
|
Scientific Title of Study
|
Role of Amblyopia Management following Surgery for Paediatric Retinal Detachment :A Pilot Randomised Control Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Ankita Matwa |
| Designation |
Junior Resident |
| Affiliation |
Aiims New Delhi |
| Address |
DDR,3RD FLOOR, Dr.R.P Centre for Ophthalmic Sciences AIIMS, New Delhi, Ansari Nagar, South Delhi
Dr.R.P Centre for Ophthalmic Sciences AIIMS, New Delhi, Ansari Nagar, South Delhi
South
DELHI
110049
India |
| Phone |
8949916927 |
| Fax |
|
| Email |
ankitamatwa9090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ankita Matwa |
| Designation |
Junior Resident |
| Affiliation |
Dr.R.P Centre for Ophthalmic Sciences AIIMS,110029, New Delhi, Ansari Nagar, South Delhi |
| Address |
DDR,3RD FLOOR, Dr.R.P Centre for Ophthalmic Sciences AIIMS,110029, New Delhi, Ansari Nagar, South Delhi
South
DELHI
110029
India |
| Phone |
8949916927 |
| Fax |
|
| Email |
ankitamatwa9090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Matwa |
| Designation |
Junior Resident |
| Affiliation |
Dr.R.P Centre for Ophthalmic Sciences AIIMS,110029, New Delhi, Ansari Nagar, South Delhi |
| Address |
DDR,3RD FLOOR, Dr.R.P Centre for Ophthalmic Sciences AIIMS,110029, New Delhi, Ansari Nagar, South Delhi
South
DELHI
110029
India |
| Phone |
8949916927 |
| Fax |
|
| Email |
ankitamatwa9090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims New Delhi
Sri Aurobindo Marg, Ansari Nagar East New Delhi, delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
AIIMS, NEW DELHI, ANSARI NAGAR , SOUTH DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANKITA MATWA |
AIIMS, NEW DELHI |
DDR,3RD FLOOR, Dr.R.P Centre for Ophthalmic Sciences AIIMS,110029, New Delhi, Ansari Nagar, South Delhi , India
South
DELHI |
8949916927
ankitamatwa9090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences situated at Room No. 102, 1st Floor, Old O.T.Block, An |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention for post retinal detachment surgery for amblyopia |
No patching will be done |
| Intervention |
Patching of eye |
Patching for 6hrs to be done in healthy eye to be daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with retinal detachment having visual aquity more than 3/60 in snellens chart |
|
| ExclusionCriteria |
| Details |
Children with syndromic association or having obvious pathologies affecting vision e.g.choroidal rupture, sub macular haemorrhage |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual acuity using snellens chart |
1. Preoperative
2. 10 +/- 4 days of RD surgery
3. 4 weeks of RD surgery
4. 8 weeks of RD surgery
5. 12 weeks of RD surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MRI changes after ambyopia therapy in patient who underwent retinal detachment surgery |
1. Preoperative
2. 12 weeks |
|
|
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)
|
15/03/2026 |
| 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="6"
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
|
This is a randomized controlled trial evaluating the role of structured amblyopia management after paediatric retinal detachment surgery. Amblyopia, a potentially reversible reduction in best-corrected visual acuity due to visual deprivation or abnormal binocular interaction, is common in children and responds best to early intervention. Despite successful retinal reattachment, many children experience suboptimal visual recovery, possibly due to prolonged image defocus during postoperative rehabilitation. The study hypothesizes that amblyopiogenic factors contribute to poor visual outcomes and that early amblyopia therapy can improve vision. Thirty children aged 4–12 years with successful retinal reattachment will be randomized into intervention and control groups. Visual acuity improvement at 6 and 12 weeks is the primary outcome, while secondary outcomes include functional MRI changes. Conducted at RP Centre, AIIMS New Delhi, this open-label pilot study aims to address a key gap in current paediatric retinal detachment management and potentially influence postoperative rehabilitation protocols. |