Comparison of techniques of stem cell transplantation in patients with bilateral ocular surface disease

Comparative evaluation of the efficacy of conjunctival stem cell transplantation with cultivated oral mucosal epithelial transplantation in patients with bilateral cicatrizing ocular surface diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17247726

Enrollment

Registered

2024-07-17

Start date

2018-01-10

Completion date

Unknown

Last updated

2024-11-04

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

Conditions

Reconstruction of ocular surface by using stem cell therapy in patients with ocular surface disease Eye Diseases

Interventions

Cultivated Oral Mucosal Epithelial Transplantation (COMET) and Conjunctival Cultivated Epithelial Transplantation (CCET) for ocular surface reconstruction in patients with bilateral ocular surface dis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pediatric patients from the age group 5-18 years old 2. Adult patients from the age group above 18 years old 3. Unilateral and bilateral ocular burns i.e. Steven Johnson syndrome and chemical burns 4. In unilateral affected patients limbal area affected should be 6 - 9 clock hours 5. Schirmer test value of at least 5 mm 6. Willing to follow-up for at least 6 months 7. No systematic disorder contradicting surgical intervention 8. Patients in whom primary insult occurred at least >4 months ago

Exclusion criteria

Exclusion criteria: Untreated concurrent problems, such as adnexal problems, glaucoma and infection

Design outcomes

Primary

Measure	Time frame
The following primary outcome measures were assessed at baseline, post-op weeks 1, 2 and 4, and months 2, 3 and 6: 1. Surgical success, defined as complete epithelization and a clinically stable corneal surface, evaluated through slit lamp biomicroscopy and clinical photographs measured using ImageJ software 2. Vascularization, defined as a complete success if the cornea is avascular and partial success if there is mild vascularization not reaching up to the centre of the cornea which is completely epithelized, assessed by using slit lamp biomicroscopy and clinical photographs measured using ImageJ software 3. Conjunctivalization, defined as a complete success if there is an absence of conjunctivalization and a partial success if there is mild conjunctivalization, examined by using slit-lamp biomicroscopy and clinical photographs measured using ImageJ software	—

Measure

Time frame

The following primary outcome measures were assessed at baseline, post-op weeks 1, 2 and 4, and months 2, 3 and 6: 1. Surgical success, defined as complete epithelization and a clinically stable corneal surface, evaluated through slit lamp biomicroscopy and clinical photographs measured using ImageJ software 2. Vascularization, defined as a complete success if the cornea is avascular and partial success if there is mild vascularization not reaching up to the centre of the cornea which is completely epithelized, assessed by using slit lamp biomicroscopy and clinical photographs measured using ImageJ software 3. Conjunctivalization, defined as a complete success if there is an absence of conjunctivalization and a partial success if there is mild conjunctivalization, examined by using slit-lamp biomicroscopy and clinical photographs measured using ImageJ software

—

Secondary

Measure	Time frame
The following secondary outcome measures were assessed at baseline, post-op weeks 1, 2 and 4, and months 2, 3 and 6: 1. Improvement in best corrected visual acuity (BCVA) measured using a Snellen Visual acuity Chart 2. Improvement in corneal transparency evaluated by using slit-lamp biomicroscopy and measured using a clinical photograph and corneal grading system	—

Countries

India

Contacts

Public ContactRadhika Tandon

radhikatandon@aiims.edu+91 011 2965 93145

Outcome results

None listed

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