| CTRI Number |
CTRI/2023/11/059379 [Registered on: 01/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Understanding the Eye related changes following eye or head injury |
|
Scientific Title of Study
|
Traumatic Optic Neuropathy Treatment study (TONT study) |
| Trial Acronym |
TNOT study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kowsalya Akkayasamy |
| Designation |
Senior Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Neuro Clinic
Room No 60
1st Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
dr.kowsalya@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kowsalya Akkayasamy |
| Designation |
Senior Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Neuro Clinic
Room No 60
1st Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
dr.kowsalya@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kowsalya Akkayasamy |
| Designation |
Senior Medical Consultant |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Neuro Clinic
Room No 60
1st Floor
OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
dr.kowsalya@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aurolab
No 1 Veerapanjan
Sivagangai Main Road
Madurai
Tamil Nadu 625020 |
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1 Veerapanjan
Sivagangai Main Road
Madurai
Tamil Nadu 625020 |
| Type of Sponsor |
Other [Private Trust] |
|
|
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 Kowsalya Akkayasamy |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
Neuro Clinic
Room No 60
1st Floor OPD Block
No1 Anna Nagar
Madurai
TAMIL NADU |
914524356100
914522530984
dr.kowsalya@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: H470||Disorders of optic nerve, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical treatment with high or megadoses of methylprednisolone |
3 days treatment |
| Comparator Agent |
Medical treatment with high or Megadoses of methylprednisolone and Recombinant Human Erythropoietin
|
3 days treatment |
| Intervention |
Recombinant Human Erythropoietin |
3 days treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Having indirect traumatic optic neuropathy (with normal eye and fundus exam)
b) Trauma to treatment interval of 2 weeks and less
|
|
| ExclusionCriteria |
| Details |
a) Direct optic neuropathy
b) Glaucoma
c) Any retinopathy
d) Globe laceration
e) Hypertension
f) Polycythaemia
g) Creatinine more than 3 mg/dl,
h) Patients who have received any other form of treatment for their traumatic optic neuropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Participants with Change/Improvement Visual Acuity From the Baseline [Time Frame: Change from baseline at least 3 months after treatment] |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relative Afferent Pupillary Defect, Color Vision, Side Effects |
3 months |
|
|
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)
Modification(s)
|
01/01/2024 |
| 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="0"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
· Change
in Mean number of visible colour plates in Colour vision test book. It is from
21/21 to 0/21 as assessed by Ishihara 21-plate colour test book
[ Time Frame: Before treatment and on day 1,2,3, 7, 30, and 90
days after the treatment and through study completion, an average of 24
months ]
· Number
of patients with treatment related adverse effects as assessed by history
taking (change in mood, vertigo, faint), examination (blood pressure) history
taking (change in mood, vertigo, faint), examination (blood pressure) and blood
tests (RBS, CBC, BUN, Cr., K, Hb) will be performed on baseline visit and at
Month 1 and 3; blood tests (RBS, Hb) will be performed on day 1, 2 and 3 (before
injection). |