Using labial mucosal grafts to treat corneal limbus deficiency

Efficiency and Safety of Labial Mucosal Epithelium Grafting for Corneal Reepithelization in Patients With Bilateral Non-immunogenic Limbal Stem Cell Deficiency

This study is testing a new surgery that uses tissue from the lips to help people with a specific eye condition called limbal stem cell deficiency improve their corneal health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution (Government)
• Locations: 1 site (Moscow)
• Trial ID: NCT04995926 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel surgical technique that utilizes labial mucosal epithelium grafts as a substitute for corneal limbus in patients suffering from bilateral limbal stem cell deficiency (LSCD). The approach aims to improve corneal re-epithelization by leveraging the histological similarities between labial mucosa and normal corneal tissue. Participants will undergo the grafting procedure, and the study will assess the feasibility and effectiveness of this intervention in restoring corneal health. Previous studies have shown promising outcomes with similar techniques, indicating potential for success in this trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with bilateral limbal stem cell deficiency due to non-immunogenic causes.

Not a fit: Patients with immunogenic causes of limbal stem cell deficiency or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with limbal stem cell deficiency, potentially improving their vision and quality of life.

How similar studies have performed: Previous studies using similar grafting techniques have reported positive outcomes, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Man or woman 18 years and older.
* Signed informed consent, given by the participant or his/her legal representative.
* Ability to understand Russian spoken and written language.
* Sanitated oral cavity.
* Bilateral limbal stem cell deficiency diagnosed by two or more symptoms during slit-lamp examination: corneal conjunctivalization, absence of palisades of Vogt, superficial corneal neovascularization, recurrent or persistent corneal epithelium erosion.
* Bilateral limbal stem cell deficiency non-immunogenic etiology (burns, irradiation, contact lens related, etc.).
* Best-corrected visual acuity less than 0.3 (6/18 Snellen chart)
* Intraocular pressure in normal range.
* Schirmer's test I more than 5 mm.

Exclusion Criteria:

* Inability to give signed informed consent.
* Age under 18 years.
* Pregnancy and/or breastfeeding.
* Hormonal contraceptives intake.
* History of allergic reactions to antibiotics, glucocorticosteroids, remedies for treatment dry eye syndrome, medications for local and general anesthesia.
* Participation in other clinical trials.
* Systemic immunosuppression intake.
* Diagnosed neoplastic process or treatment for it.
* Positive tests for infectious: HIV, syphilis, Hepatitis B, Hepatitis C.
* Any medical, psychiatric and/or condition, including cachexia, or social conditions that the investigator believes would interfere with or contraindicate adherence to the research protocol or the ability to provide signed informed consent.
* Immune-mediated limbal stem cell deficiency (Stevens-Johnson syndrome, ocular cicatricial pemphigoid and other.), unknown and/or inherited etiology.
* Best-corrected visual acuity more than 0.3 (6/18 Snellen chart)
* Ocular burns earlier than 12 months.
* Keratoplasty earlier than 12 months.
* Limbal grafting (from postmortem or living-related donors).
* Keratoprosthetic device or history of its implantation.
* Cellular therapy for treatment of limbal stem cell deficiency.
* Cellular transplantation for treatment of limbal stem cell deficiency.
* Active ophthalmic infection.
* Symblepharon, ectropion, trichiasis, lagophthalmos and/or other lid and/or conjunctival fornixes abnormalities.
* Surgery on ocular adnexa earlier than 9 months.
* Corneal stromal thickness less than 300 mkm.
* Dry eye with Schirmer test I less than 5 mm and/or keratinized ocular surface.
* Uncontrolled glaucoma and/or presents of a glaucoma drainage device.
* Retinal defunctioning (no light perception and/or retinal detachment).
* Absence of the electric activity of the optic nerve and/or retina.

Where this trial is running

Moscow

• The S. Fyodorov Eye Microsurgery Federal State Institution — Moscow, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Boris E Malyugin, MD PhD Prof — The S. Fyodorov Eye Microsurgery Federal State Institution
• Study coordinator: Boris E. Malyugin, MD PhD Prof.

Conditions Limbal Stem-cell Deficiency; Limbal Stem Cell Deficiency