Study on surgical procedure for eye surface healing and regeneration

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) - LHES HARC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098224

Enrollment

Registered

2025-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: LHES HARC Technique: Surgical intervention. Limbal epithelium Hashed & Encapsulated in Scaffold- Hybrid Approach to regenerate the corneal epithelium. Name of Product : Festigel Dose

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 1. Clinical Success : 6 Months 2. Clinical Failure : 6 Months	—

Secondary

Measure	Time frame
1. Visual Function Improvement : Change in best-corrected visual acuity (BCVA) 2. Intraocular Pressure 3. Corneal Surface Imaging 4. Ocular Surface Documentation 5. Epithelial IntegrityTimepoint: 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.	—

Measure

Time frame

1. Visual Function Improvement : Change in best-corrected visual acuity (BCVA) 2. Intraocular Pressure 3. Corneal Surface Imaging 4. Ocular Surface Documentation 5. Epithelial IntegrityTimepoint: 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.

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Countries

India

Contacts

Public ContactDr Preethy SP

MediNippon Healthcare Pvt. Ltd.

rd1@medinippon.jp9444927694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026