| CTRI Number |
CTRI/2025/11/098224 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on surgical procedure for eye surface healing and regeneration |
|
Scientific Title of Study
|
An Open Labelled, Prospective Study To Assess The Safety And Efficacy Of Limbal Epithelium Hashed & Encapsulated In Scaffold- Hybrid Approach To Regeneration Of The Corneal Epithelium (LHES-HARC) |
| Trial Acronym |
LHES HARC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LHES HARC |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr B Pramila |
| Designation |
Principal Investigator |
| Affiliation |
Madras Medical College |
| Address |
Room no: 104, Department of Cornea and Contact Lens Services,
Regional Institute of Ophthalmology and Government Ophthalmic Hospital,
Rukmani Lakshmipathi Road, Pudupet, Egmore,
Chennai - 600008
Chennai
TAMIL NADU
600003
India |
| Phone |
04428555281 |
| Fax |
|
| Email |
drpramila71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethy SP |
| Designation |
Sponsor Representative |
| Affiliation |
MediNippon Healthcare Pvt. Ltd. |
| Address |
No. 6, Zachariah Colony 3rd Street,
Choolaimedu,
Chennai
TAMIL NADU
600094
India |
| Phone |
9444927694 |
| Fax |
|
| Email |
rd1@medinippon.jp |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preethy SP |
| Designation |
Sponsor Representative |
| Affiliation |
MediNippon Healthcare Pvt. Ltd. |
| Address |
No. 6, Zachariah Colony 3rd Street,
Choolaimedu,
TAMIL NADU
600094
India |
| Phone |
9444927694 |
| Fax |
|
| Email |
rd1@medinippon.jp |
|
|
Source of Monetary or Material Support
|
| MediNippon Healthcare Pvt. Ltd.
No. 6, Zachariah Colony
3rd Street, Choolaimedu,
Chennai – 600094, India |
|
|
Primary Sponsor
|
| Name |
MediNippon Healthcare Pvt. Ltd. |
| Address |
No. 6, Zachariah Colony 3rd Street, Choolaimedu, Chennai – 600094, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr B Pramila |
Madras Medical College |
Room no: 104, Department of Cornea and Contact Lens Services,
Regional Institute of Ophthalmology and Government Ophthalmic Hospital,
Rukmani Lakshmipathi Road, Pudupet, Egmore, Chennai. 600008
Chennai
TAMIL NADU |
04428555281
drpramila71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LHES HARC Technique |
Surgical intervention.
Limbal epithelium Hashed & Encapsulated in Scaffold- Hybrid Approach to regenerate the corneal epithelium.
Name of Product : Festigel
Dose & Dosage : Not Applicable.
Intended Use : Festigel functions as a biocompatible support structure for encapsulating and transplanting cells, enabling them to grow and repair damaged tissue. |
| Comparator Agent |
None. Non Comparative single arm Study |
None. Non Comparative single arm Study |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 10 and 90 years.
2. The affected eye must present with at least grade 2 limbal stem cell deficiency LSCD.
3. The affected eye shows clinical signs of LSCD, including recurrent corneal erosion and corneal neovascularization.
4. Symptoms must have persisted for a minimum of 6 months and shown no improvement with conventional medical treatment.
|
|
| ExclusionCriteria |
| Details |
1. Symptoms of corneal damage that improve spontaneously or with medication alone.
2. Inability to comply with regular post-operative follow-up examinations.
3. Patients with an overall poor prognosis due to systemic or ocular conditions.
4. Presence of uncorrected severe lagophthalmos or trichiasis.
5. Evidence of active ocular infection in the affected eye.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical Success : Fully epithelized, stable, and avascular corneal surface
2. Clinical Failure : Recurrence of central fibrovascular pannus, frequent epithelial breakdown, or persistent epithelial defects requiring repeat intervention
|
1. Clinical Success : 6 Months
2. Clinical Failure : 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Function Improvement : Change in best-corrected visual acuity (BCVA)
2. Intraocular Pressure
3. Corneal Surface Imaging
4. Ocular Surface Documentation
5. Epithelial Integrity |
1. Visual Function Improvement : 6 months
2. Intraocular Pressure : Post Operative Days 1, 3, 7, 15, 30, 60, and 90.
3. Corneal Surface Imaging : Post Operative Days 1, 3, 7, 15, 30, 60, and 90.
4. Ocular Surface Documentation : Post Operative Days 1, 3, 7, 15, 30, 60, and 90.
5. Epithelial Integrity : Post Operative Days 1, 3, 7, 15, 30, 60, and 90. |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
12/12/2025 |
| 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="0"
Months="6"
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
|
Study Design : An open label, prospective, interventional surgical study.
Indication : Limbal Stem Cell Deficiency (LSCD)
Intervention : LHES HARC (Limbal Epithelium Hashed & Encapsulated in Scaffold-Hybrid Approach to Regeneration of the Corneal Epithelium Study Population : Patients diagnosed with limbal stem call deficiency. Outcome Measures
1. Clinical Success/Failure
2. Visual Function Improvement
3. Intraocular Pressure
4. Corneal Surface Imaging
5. Ocular Surface Documentation
6. Epithelial Integrity
7. Healing timelines of LHES HARC with conventional methods like SLET or CLAU with historical data if available. Background: The corneal epithelium, the transparent outermost layer
of the eye, is highly vulnerable to damage caused by trauma, burns, chemical
injuries, and diseases such as Stevens-Johnson syndrome. Corneal epithelial damage,
particularly persistent epithelial defects (PEDs), represents a major global
health burden, contributing significantly to the incidence of corneal
blindness, which affects over 10
million individuals worldwide.
Following are the cell and tissue transplantation techniques for corneal
epithelial diseases that have been reported.
1. Cultivated Limbal Epithelial
Transplantation (CLET)
2. Cultivated autologous limbal
epithelial cells (CALEC)
3.
Conjunctival-Limbal Autografting (CLAU)
4. Simple
Limbal Epithelial Transplantation (SLET)
Purpose : To prospectively evaluate the efficacy of
Limbal epithelium Hashed & Encapsulated in Scaffold- Hybrid Approach to
Regeneration of the Corneal epithelium (LHES-HARC).
|