| CTRI Number |
CTRI/2026/01/100898 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing 2 visual field tests in patients with vision problems after stroke |
|
Scientific Title of Study
|
Precision Mapping of Post-Stroke Visual Impairment: Comparing Head Mounted Virtual Perimetry and Automated Humphrey Perimetry with Radiologically Identified Visual Pathway Lesions. |
| 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 Anushree DK |
| Designation |
secondary DNB |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room No.120, Neuro-opthalmology Department ,Aravind Eye Hospital, Cuddalore Main Road Thavalakuppam Pondicherry-605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9740213616 |
| Fax |
|
| Email |
dk.anushree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balraj A |
| Designation |
Head of Neuro-ophthalmology Department |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room NO 120, Department of Neuro-ophthalmology Aravind Eye Hospital, Aravind Eye Hospital, Cuddalore Main Road Thavalakuppam Pondicherry-605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8870325090 |
| Fax |
|
| Email |
balrajopthal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balraj A |
| Designation |
Head of Neuro-ophthalmology Department |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room No 120, Department of Neuro-ophthalmology Aravind Eye Hospital, Aravind Eye Hospital, Cuddalore Main Road Thavalakuppam Pondicherry-605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8870325090 |
| Fax |
|
| Email |
balrajopthal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Abishekapakkam Road, Puducherry-605007 |
|
|
Primary Sponsor
|
| Name |
Dr.Anushree DK |
| Address |
Secondary DNB,Aravind Eye Hospital, Abishekapakkam Road, Puducherry-605007 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Anushree DK |
Department of Neuro ophthalmology |
Room No 120, Department of Neuro-ophthalmology ,Aravind Eye Hospital Cuddalore Main Road, Thvalakuppam, Puducherry, 605007
Pondicherry
PONDICHERRY |
9740213616
dk.anushree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AEH-P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above
2. MRI evidence of lesions involving the visual pathways (optic tract, lateral geniculate body, optic radiations, or occipital cortex).
3. Capable of providing informed consent and cooperating with perimetry testing.
4. Best corrected visual acuity of 6/60 or better in at least one eye.
|
|
| ExclusionCriteria |
| Details |
1. Stroke patients with brainstem lesions only.
2. Presence of ocular diseases affecting the retina or optic nerve (e.g., glaucoma, retinitis pigmentosa, optic atrophy unrelated to stroke).
3. Severe cognitive impairment, aphasia, or psychiatric illness affecting test performance.
4. Inability to complete either perimetry test.
5. Pre-existing diagnosed visual field defects from causes other than stroke.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the head-mounted virtual perimetry and automated Humphrey perimetry in detecting visual field deficits in post-stroke patients.
|
At baseline/ At single visit/Same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To correlate visual field defects from both modalities with radiologically identified visual pathway lesions. |
At baseline/ At single visit/Same day |
2. To evaluate patient comfort & compliance using a structured questionnaire after perimetry.
|
At baseline/ At single visit/Same day |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
22/01/2026 |
| 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="0"
Months="10"
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
|
Stroke commonly results in visual field defects due to involvement of the visual pathways. Accurate assessment of visual field loss is essential for diagnosis, functional evaluation, and rehabilitation planning in post stroke patients. Automated Humphrey visual field analysis is the standard method for visual field assessment, but it requires good fixation and patient cooperation, which may be difficult in stroke patients.
Head mounted virtual reality based perimetry is a newer technique that allows visual field testing in a more flexible and patient friendly manner.
This is a prospective observational study conducted to compare head-mounted virtual reality perimetry with automated Humphrey perimetry in patients with visual field defects following stroke. The primary outcome of the study is to compare the pattern and extent of visual field defects, reliability indices and test duration of virtual reality perimetry with automated Humphrey perimetry. The secondary outcomes include correlation of visual field defects identified by both perimetric modalities with radiologically documented visual pathway lesions and assessment of patient comfort, ease of test performance, and compliance using a structured questionnaire following perimetry. The study will be conducted at a tertiary eye care centre in India over a period of ten months. |
