| CTRI Number |
CTRI/2025/09/094915 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Light Guided Eye Pressure Control Surgery |
|
Scientific Title of Study
|
Prospective Study To Evaluate The Safety And Efficacy Of ICath Device In Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) Versus Combined Trabeculotomy And Trabeculectomy In Patients With Primary Congenital Glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srisha Senthil |
| Designation |
Consultant |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Hyderabad Eye Research Foundation,
LV Prasad Eye Institute,
1st Floor Clinical Research Department
Room no 207,
GPR Building Kallam Angi Reddy Campus,
Banjara Hills Road no2 Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9849171131 |
| Fax |
|
| Email |
sirishasenthil@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srisha Senthil |
| Designation |
Consultant |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Hyderabad Eye Research Foundation,
LV Prasad Eye Institute,
1st Floor Clinical Research Department
Room no 207,
GPR Building Kallam Angi Reddy Campus,
Banjara Hills Road no2 Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9849171131 |
| Fax |
|
| Email |
sirishasenthil@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srisha Senthil |
| Designation |
Consultant |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Hyderabad Eye Research Foundation,
LV Prasad Eye Institute,
1st Floor Clinical Research Department
Room no 207,
GPR Building Kallam Angi Reddy Campus,
Banjara Hills Road no2 Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9849171131 |
| Fax |
|
| Email |
sirishasenthil@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1 Sivanganga road
Veerapanjan
Madurai
Tamil Nadu 625020 |
| Type of Sponsor |
Other [Trust] |
|
|
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 Ganesh V Raman |
Aravind Eye Hospital |
Avinashi Road,
Peelamedu Civil,
Coimbatore 641014
Coimbatore
TAMIL NADU |
9786649735
ganeshvr75@gmail.com |
| Dr Srisha Senthil |
LV Prasad Eye Institute |
1st Floor Clinical Research Department,
Room No 207,
GPR Building Kallam Angi Reddy Campus,
Banjara Hills Road No 2
Hyderabad
Hyderabad
TELANGANA |
9849171131
sirishasenthil@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee PSG Institute of Medical Sciences and Research |
Approved |
| LV Prasad Eye Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
Standard combined Trabeculotomy and trabeculectomy
&
Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) |
Trabeculotomy involves opening a part of the trabecular meshwork and Schlemms canal, creating a new pathway for aqueous humor to exit the eye.
Trabeculectomy involves a surgically formed pathway for aqueous humor between the
AC and subconjunctival space.
An illuminated flexible microcatheter will be used to visualize in the Schlemm’s canal to perform 360 degree trabeculotomy. The lighted tip to guide the catheter minimizes potentially devasting inadvertent misdirection into the suprachoroidal or subretinal space by verification of the
microcatheter location within Schlemm’s canal. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Day(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 15 days to 3 years (surgery will be performed as per physician fitness)
2 Typical Primary Congenital Glaucoma with grade 1 to 4 corneal haze
3 Parents of the patient is willing and able to comply with study procedures and sign
informed consent |
|
| ExclusionCriteria |
| Details |
1 PCG operated earlier
2 PCG with central cleft or grade 5 corneal haze
3 PCG with HCD greater than 13 mm at the time of surgery
4 Patients with any other types of secondary glaucoma
5 Patients with any other ocular diseases.
6 Not willing to participate or come for follow up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 IOP
2 Ocular examination
3 Minimal or no anti glaucoma medication
4 Stable AL and refractive error
5 Complications |
Pre op
Post operative day 1
Post operative day 15 or 1 month
Post operative day 3 months
Post operative day 6 months
Post operative day 8 months
Post operative day 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The most common cause of glaucoma in the pediatric population is primary congenital glaucoma (PCG) which can have devasting visual consequences. The management is surgical and to create fluid outflow pathway by surgeries including goniotomy and trabeculotomy or trabeculectomy. Specifically in cases of hazy corneas, combined trabeculotomy with trabeculectomy ab externo is the preferred initial surgery
Illuminated microcatheter assisted trabeculotomy has emerged as a good surgical alternative with improved success rates compared to conventional CTT. The lighted tip to guide the catheter minimizes potentially devasting inadvertent misdirection into the suprachoroidal or subretinal space by verification of the microcatheter location within Schlemm’s canal.
The purpose of this study is to evaluate the safety and efficacy of ICath device for Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) and compare with Combined Trabeculotomy and Trabeculectomy in patients with Primary Congenital Glaucoma. The objective of the study is to evaluate the safety and efficacy of I Cath device using Illuminated Microcatheter Assisted Transluminal Trabeculotomy (iMAT) compared Combined Trabeculotomy and Trabeculectomy in patients with Primary Congenital Glaucoma. The study will include treatment Naïve PCG children, with no central corneal scar or cleft and corneal diameter not greater than 13 mm. |