| CTRI Number |
CTRI/2026/02/102702 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigator Initiated Pilot Study Evaluating Low Dose Pilocarpine for Migraine Related Disability and Photophobia |
|
Scientific Title of Study
|
Pilot Study on the Effect of Low Strength Pilocarpine in Reducing Migraine Associated Disability and Photophobia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruby Moharana |
| Designation |
Consultant |
| Affiliation |
Apex Eye Care |
| Address |
Neuroophthalmology Department,
Apex Eye Care,
Kathagola Road,
Mangalabag,
Cuttack
Apex Eye Care,
Kathagola Road,
Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India |
| Phone |
7428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruby Moharana |
| Designation |
Consultant |
| Affiliation |
Apex Eye Care |
| Address |
Neuroophthalmology Department,
Apex Eye Care,
Kathagola Road,
Mangalabag,
Cuttack
Apex Eye Care,
Kathagola Road, Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India |
| Phone |
7428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruby Moharana |
| Designation |
Consultant |
| Affiliation |
Apex Eye Care |
| Address |
Neuroophthalmology Department,
Apex Eye Care,
Kathagola Road,
Mangalabag,
Cuttack
Apex Eye Care,
Kathagola Road, Mangalabag, Cuttack - 753001
Cuttack
ORISSA
753001
India |
| Phone |
7428968090 |
| Fax |
|
| Email |
rubymoharana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ruby Moharana |
| Address |
Apex Eye Care,
Kathagola Road,
Mangalabag, Cuttack - 753001,
Odisha, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Ruby Moharana |
Apex Eye Care |
Neuroophthalmology Department,
Kathagola Road,
Mangalabag,
Cuttack - 753001
Cuttack
ORISSA |
7428968090
rubymoharana@gmail.com |
| Dr Goura Chattannavar |
LV Prasad Eye Institute |
Jasti V Ramanamma Childrens Eye Care Centre,
Kallam Anji Reddy Campus
Banjara Hills, Hyderabad
500034
Hyderabad
TELANGANA |
9844602898
drgourachattannavar@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JPM Rotary Eye Hospital |
Approved |
| L V Prasad Eye Institute Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.125% pilocarpine- No Comparator |
Informed consent will be obtained from all the 50 eligible participants. Pupil size will be measured in all Participants with IOL Master 700 in photopic conditions. 0.125% pilocarpine drops will be instilled in both eyes of the study group and the pupil size will be remeasured after 60 minutes. Participants will be asked about any change in photosensitivity after putting the drops. Participants will be given the drop to be instilled twice daily 4 hours apart with the first drop to be instilled in the morning time preferably 30 minutes prior to any outdoor activity. The HIT-6 scores will be taken after a period of 1 month and the MIDAS scores will be taken after a period of 3 months. The pre and post scores will be compared. Participants will be asked for any adverse events and same will be recorded in CRF. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants meeting ICD 3 criteria for migraine
Participants having migraine with photophobia with light as the trigger factor for migraine
Patients with BCVA of 6/6
Patients with normal anterior and posterior segment and normal IOP
Patients with normal neurological assessment and normal MRI
Patients volunteering to answer physicians questionnaire on HIT 6 and MIDAS |
|
| ExclusionCriteria |
| Details |
- Participants with no associated neurological disorder
- Participants with no pre existing ocular conditions affecting pupil size
- Participants with no recent eye surgeries
- Participants not 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 assess the impact of the 0.125% pilocarpine drops in reducing migraine-related disability using HIT-6 (Headache Impact Test) scores and MIDAS (Migraine Disability Assessment) scores. |
Day 0, Day 30 (HIT-6 scores), Day 90 (MIDAS Scores) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 0.125% pilocarpine on the pupil sizes of migraine patients with photophobia. |
Day 30, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/02/2026 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 literal meaning of photophobia is fear of light. 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. Recently the author 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 checked the pupil sizes in patients of severe migraine with photophobia, the effect of 0.125% pilocarpine eye drops on the pupil sizes and whether the drops could help reduce photophobia which is a major trigger for the migraine attacks. |