| CTRI Number |
CTRI/2026/02/102852 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the treatment outcomes in eye disease progression in preterm babies |
|
Scientific Title of Study
|
Outcomes of topical Ringers Lactate solution as treatment for Phase – 1 Retinopathy of Prematurity |
| 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 Vignesh Elamurugan |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Room Number 207
2nd Floor OPD Block
Vitreous-Retina Services
N
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
vignesh.elamurugan@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vignesh Elamurugan |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Room Number 207
2nd Floor OPD Block
Vitreous-Retina Services
N
No 1 Anna Nagar
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
vignesh.elamurugan@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh Elamurugan |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Room Number 207
2nd Floor OPD Block
Vitreous-Retina Services
N
No 1 Anna Nagar
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
|
| Email |
vignesh.elamurugan@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
Room Number 207 2nd Floor OPD Block Vitreous-Retina Services No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Room Number 207 2nd Floor OPD Block Vitreous-Retina Services No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| 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 Vignesh Elamurugan |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
Room Number 207
2nd Floor OPD Block
Vitreous Retina Services
No 1 Anna Nagar
Madurai
TAMIL NADU |
914524356100
vignesh.elamurugan@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Observation |
Preterm neonate will be regularly reviewed for a maximum of 6 months or till retinal vascularization is complete or till stages of ROP develop. If required, standard of care treatment will be provided. |
| Intervention |
Ringers Lactate eye drops |
6 times per day administered topically for a maximum of 6 months or until retinal vascularization is complete or till stages of ROP develop.
If stages of ROP develop, Ringers Lactate treatment will be stopped. If the stage progresses to treatable ROP, standard of care treatment will be provided |
|
|
Inclusion Criteria
|
| Age From |
6.50 Month(s) |
| Age To |
7.50 Month(s) |
| Gender |
Both |
| Details |
Preterm neonates born between 26 to 30 weeks of gestational age |
|
| ExclusionCriteria |
| Details |
a)Preterm neonates with stages of Retinopathy of Prematurity
b)Preterm neonates born between 26 - 30 weeks of gestational age
c)Preterm neonates with any other fundus abnormality
d)Systemically unstable neonates
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name - Development of retinal vascularization or
stages of Retinopathy of Prematurity |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Development of retinal vascularisation or stages of Retinopathy of Prematurity
b) Refractive status |
6 months |
|
|
Target Sample Size
|
Total Sample Size="4"
Sample Size from India="4"
Final Enrollment numbers achieved (Total)= "4"
Final Enrollment numbers achieved (India)="4" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2026 |
| Date of Study Completion (India) |
20/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Four preterm neonates were enrolled in the study. Among the four neonates, one developed Staged ROP (Phase 2) approximately two weeks earlier in the untreated eye compared to the treated eye. Two neonates showed simultaneous progression to staged ROP in both eyes, and one neonate was lost to follow-up. No local or systemic adverse effects were observed during the study period. This pilot study demonstrates a favorable local and systemic safety profile of topical Ringer’s lactate. However, further studies, including dose-escalation trials with larger sample sizes, are required to evaluate its efficacy in preventing progression from Phase 1 to Phase 2 ROP. |