| CTRI Number |
CTRI/2026/01/100376 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Can Basic Eye Exams Indicate Brain Recovery Following a Brain Aneurysm Bleed?
Research on how eye responses might predict neurological results in individuals with subarachnoid bleed.-THE OPTICS STUDY |
|
Scientific Title of Study
|
AutOmated Pupillometry and OpTic nerve sheath dIameter for prediCtion of neurological outcome in patients with aneurysmal Subarachnoid hemorrhage– the OPTICS study |
| Trial Acronym |
OPTICS STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RICHA PARIHAR |
| Designation |
SENIOR RESIDENT( ACADEMIC) |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES NEW DELHI |
| Address |
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7697220212 |
| Fax |
|
| Email |
richaparihar2807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Charu Mahajan |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES NEW DELHI |
| Address |
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RICHA PARIHAR |
| Designation |
SENIOR RESIDENT( ACADEMIC) |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCES NEW DELHI |
| Address |
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7697220212 |
| Fax |
|
| Email |
richaparihar2807@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029
India |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029 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 |
| RICHA PARIHAR |
AIIMS |
Department of Neuroanaesthesiology and Neurocritical care, AIIMS ,Sri Aurobindo marg, Ansari Nagar East, New Delhi 110029 India
New Delhi
DELHI |
7697220212
richaparihar2807@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| aiims ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Adult patients (more than 18 years) with a confirmed diagnosis of aSAH
b) less than 5 days of ictus
c) Able to undergo non-invasive testing ONSD measurement and AP.
|
|
| ExclusionCriteria |
| Details |
a) Pre-existing eye diseases or optic nerve pathology (e.g., optic neuritis, glaucoma).
b) more than 5 days of ictus
c) Requirement for immediate surgery or interventions that prevent non-invasive testing.
d) Pregnancy.
e) Significant comorbidities, such as terminal cancer, that would complicate the study’s outcome measures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extended Glasgow outcome scale [GOSE]) at discharge from hospital and at 3 months post aSAH |
Extended Glasgow outcome scale [GOSE]) at discharge from hospital and at 3 months post aSAH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality within 30 days of aSAH.
2. Delayed cerebral ischemia or vasospasm as detected on imaging or clinical examination.
3. Influence of confounding variables (age, gender, grades of aSAH, comorbidities, timing of measurement, hydrocephalus, Vasospasm, DCI, infarct) on predictive accuracy of ONSD & Pupillometry.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All participants in our study will be evaluated for various demographic parameters, such as age, gender, and comorbidities. Consciousness will be evaluated using the GCS and pupil reactivity will also be assessed. Physiological metrics (including Mean Arterial Pressure (MAP), Heart Rate (HR), Respiratory Rate (RR), and Oxygen Saturation (SpO2)), along with laboratory parameters such as blood glucose levels, serum sodium, and PaCo2 levels, will be documented. In addition, other parameters like the timing of ictus, grades of subarachnoid hemorrhage (including Hunt and Hess grade, modified Fischer’s grade, and WFNS grade), pupillary reactivity, presence of hydrocephalus, insertion of external ventricular drain and vasospasm will be recorded. Measurements of Optic Nerve Sheath Diameter (ONSD) will be conducted alongside. Automated Pupillometry (AP) measurements. These assessments will occur at baseline, as well as at 24 hours, 48 hours, and on 72 hours following admission, with trends being carefully documented. The patient’s outcome will be assessed by extended Glasgow outcome scale (GOSE) at discharge from the hospital and telephonically 3 months after the ictus. |