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)

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).