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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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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