| CTRI Number |
CTRI/2026/03/106655 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the role of Pupil Size as a biomarker of Photophobia Severity in Migraine |
|
Scientific Title of Study
|
Pupil Size as an objective Biomarker for Photophobia severity in migraine |
| Trial Acronym |
MPSIZE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruby Moharana |
| Designation |
Assistant Professor |
| Affiliation |
DRIEMS Institute of Health Sciences and Hospital |
| Address |
Neuroophthalmology Department,
Padmini Care,
DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack, Odisha Apex Eye Care, Kathagola Road, Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India Cuttack ORISSA 754022 India |
| Phone |
07428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ruby Moharana |
| Designation |
Assistant Professor |
| Affiliation |
DRIEMS Institute of Health Sciences and Hospital |
| Address |
Neuroophthalmology Department,
Padmini Care,
DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack, Odisha Apex Eye Care, Kathagola Road, Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India Cuttack ORISSA 754022 India |
| Phone |
07428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ruby Moharana |
| Designation |
Assistant Professor |
| Affiliation |
DRIEMS Institute of Health Sciences and Hospital |
| Address |
Neuroophthalmology Department,
Padmini Care,
DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack, Odisha Apex Eye Care, Kathagola Road, Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India Cuttack ORISSA 754022 India |
| Phone |
07428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ruby Moharana |
| Address |
Neuroophthalmology Department, DRIEMS Institute of Health Sciences and Hospital
Tangi, Cuttack, Odisha |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kiran Bala Bhandari |
Apex Eye Care |
Neuroophthalmology Department,
Apex Eye Care, Mangalabag, Cuttack - 753001, ORISSA, India Cuttack ORISSA |
07428968090
apexeyecarecuttack@gmail.com |
| Ruby Moharana |
DRIEMS Institute of Health Sciences and Hospital |
Neuroophthalmology Department, DRIEMS Institute of Health Sciences and Hospital
Tangi, Cuttack, Odisha Cuttack ORISSA |
07428968090
rubymoharana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack, Odisha |
Approved |
| Institutional Ethics Committee, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack, Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants meeting ICHD 3 criteria for migraine
Participants 18 to 40 years old with migraine and photophobia
Participants having light as a trigger factor for the migraine attack
Participants with best corrected visual acuity 6/6 for distance and N6 for near
Participants with normal anterior and posterior segments with normal IOP
Participants with normal neurological assessment and normal MRI brain
Participants voluntarily giving informed consent and agreed to answer the UPSIS12 Questionnaire
|
|
| ExclusionCriteria |
| Details |
Participants with associated neurological disorder
Participants with preexisting ocular conditions affecting pupil size
Participants with recent eye surgeries
Participants on any medications which can affect pupil size
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean photopic pupil size measurement and its correlation to the UPSIS 12 scores
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean photopic pupil size measurement & its correlation to the Migraine Disability Assessment scores MIDAS
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
29/03/2026 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
|
Migraine is one of the oldest reported diseases and the second most disabling disease worldwide. It affects almost 1.1 billion people worldwide and is a major cause of morbidity and disability specially in the young population. In 80 % of migraine attacks, photophobia or light sensitivity is a core component. The exact cause of photophobia in migraine is not yet known and a number of causes have been postulated like cortical hypersensitivity to light, altered ocular parasympathetic outflow, and intrinsically photosensitive retinal ganglion cell pathways acting on dura-sensitive thalamocortical neurons which in turn can influence pupillary light reflexes. At present there is no objective biomarker for photophobia in migraine and the diagnosis solely rests on symptoms that the patient reports. If we can have a quantifiable biomarker for photophobia severity in migraine then targeted therapies for photophobia can significantly reduce migraine related disability. In a recent study we reported that the patients of migraine with photophobia have a larger pupil size as compared to patients with no history of migraine and that the severity of headache correlates with a larger pupil size. In this study we want to check the effect of pupil size on the UPSIS 12 Utah Photophobia symptom Impact Scale which is a validated questionnaire on photophobia and to correlate the pupil sizes to the severity of photophobia in migraine patients. |