| CTRI Number |
CTRI/2026/02/102925 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Medications for best results after MIGS |
|
Scientific Title of Study
|
Comparison of post-operative cycloplegia, miotics, and no
treatment after Minimally Invasive Glaucoma Surgery: A Randomized Controlled Trial. |
| Trial Acronym |
Post MIGS meds |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Eye Centre,
Post Graduate Institute of Medical Education and Research,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814813207 |
| Fax |
|
| Email |
sushmita_kaushik@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Eye Centre,
Post Graduate Institute of Medical Education and Research,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814813207 |
| Fax |
|
| Email |
sushmita_kaushik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushmita Kaushik |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Eye Centre,
Post Graduate Institute of Medical Education and Research,
Sector 12,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814813207 |
| Fax |
|
| Email |
sushmita_kaushika@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NO SPONSOR |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Sushmita Kaushik |
Advanced Eye Centre |
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
9814813207
0172-2756111
sushmita_kaushik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atropine
|
Post op after MIGS surgery |
| Intervention |
MIGS |
Minimally invasive glaucoam skurgery |
| Comparator Agent |
No Drug |
PAS after surgery |
| Comparator Agent |
Pilocarpine |
PAS after MIGS surgery |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Any diagnosed case of glaucoma, undergoing MIGS during the study period. |
|
| ExclusionCriteria |
| Details |
Any patient with blood dyscrasia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The change of PAS from baseline
The extent of PAS (in clock hours)
IOP and correlation to PAS
|
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraocular Pressure |
3 months |
| Reduction in antiglaucoma meds |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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)
|
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
|
Minimally Invasive Glaucoma Surgeries (MIGS) have developed in recent years. These procedures are characterized by ab-interno microincisions, minimal trauma, a high safety profile, high efficacy, and fast recovery. Although minimally invasive glaucoma surgeries (MIGS) have made significant advancements, they are not without failures. Studies indicate that failure rates for various MIGS procedures can range from 20% to 40%. (9-11) Several factors contribute to these failures, including postoperative intraocular pressure (IOP) spikes and heightened responses to steroids. Additionally, the formation of peripheral anterior synechiae (PAS) may lead to increased IOP after surgery, which can further raise the failure rates of these procedures. Our study aims to investigate whether the use of cycloplegic drops postoperatively, which keeps the lens-iris diaphragm positioned posteriorly, can reduce the formation of PAS and lower the failure rates in patients undergoing MIGS. |