Comparison of techniques of stem cell transplantation in patients with bilateral ocular surface disease
Not Applicable
Completed
- Conditions
- Reconstruction of ocular surface by using stem cell therapy in patients with ocular surface diseaseEye Diseases
- Registration Number
- ISRCTN17247726
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
Untreated concurrent problems, such as adnexal problems, glaucoma and infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following primary outcome measures were assessed at baseline, post-op weeks 1, 2 and 4, and months 2, 3 and 6:<br>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<br>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 <br>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<br><br><br>
- Secondary Outcome Measures
Name Time Method The following secondary outcome measures were assessed at baseline, post-op weeks 1, 2 and 4, and months 2, 3 and 6:<br>1. Improvement in best corrected visual acuity (BCVA) measured using a Snellen Visual acuity Chart<br>2. Improvement in corneal transparency evaluated by using slit-lamp biomicroscopy and measured using a clinical photograph and corneal grading system<br>