| CTRI Number |
CTRI/2026/03/106722 [Registered on: 23/03/2026] 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
|
Pupil size in children with migraine headache and light sensitivity |
|
Scientific Title of Study
|
Comparision of Pupil size in Pediatric Migraine patients with photophobia versus healthy controls and its correlation to the severity of headache |
| Trial Acronym |
PPEDMIG |
|
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 |
Apex Eye Care |
| Address |
Neuroophthalmology Department, Padmini Care, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack 754022, Odisha
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 |
Apex Eye Care |
| Address |
Neuroophthalmology Department, Padmini Care, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack 754022, Odisha
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 |
Apex Eye Care |
| Address |
Neuroophthalmology Department, Padmini Care, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack 754022, Odisha
India
Cuttack ORISSA 754022 India |
| Phone |
07428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apex Eye Care, Kathagola Road, Cuttack |
|
|
Primary Sponsor
|
| Name |
Ruby Moharana |
| Address |
Neuroophthalmology Department, Padmini Care, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack 754022, 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 |
Kathagola Road, Mangalabag, Cuttack Cuttack ORISSA |
09861033156
kiranmoharana8@yahoo.com |
| Ruby Moharana |
DRIEMS Institute of Health Sciences and Hospital |
Neuroophthalmology Department, Padmini Care, DRIEMS Institute of Health Sciences and Hospital, Tangi, Cuttack 754022, 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 & Hospital, Tangi, Cuttack |
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 |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants meeting ICHD 3 criteria for pediatric migraine
Participants 8 to 18 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 assent and agreed to answer the pedMIDAS 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 |
| To evaluate the role of pupil size in patients of pediatric migraine with photophobia and its correlation to the pedMIDAS scores |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
31/03/2026 |
| 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. The ICHD-3 defines migraine as a primary headache disorder with attacks lasting 4-72 hours, typically unilateral, pulsating, moderate-to-severe, worsened by activity, and associated with nausea/vomiting and/or light/sound sensitivity (photophobia/phonophobia). Pediatric migraine is the most severe primary headache in children leading to decreased quality of life. The new ICHD-3 has increased the time window of childhood headaches for a diagnosis of primary migraine to 2–72 hours. ICHD-3 also takes cognizance of some factors unique to this condition, such as shorter pain durations and unilateral as well as bilateral pain locations. 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. 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 pupil sizes in patients of pediatric migraine with photophobia and whether it has any influence on the Migraine Disability Assessment (MIDAS) scores.
|