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Comparing cultured limbal stem cell transplantation (CLET) with direct limbal lenticule transplantation (SLET) in eyes with total limbal stem cell deficiency due to ocular burns

Comparison of autologous cultured limbal stem cells on amniotic membrane transplant (CLET) versus limbal lenticule transplantation alone (SLET) in the management of total limbal stem cell deficiency due to ocular burns: A randomised controlled clinical trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12217540
Enrollment
150
Registered
2018-09-10
Start date
2015-09-01
Completion date
Unknown
Last updated
2021-07-26

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

Conditions

Chronic ocular burns with total limbal stem cell deficiency (LSCD) Eye Diseases Chronic ocular burns with total limbal stem cell deficiency (LSCD)

Interventions

Participants will be randomly allocated into two groups using a table of random numbers. Group 1 will receive direct limbal lenticule with an amniotic membrane graft (Lenticule-LCST) transplantation.

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unilateral cases of total limbal stem cell deficiency (LSCD) due to ocular burns (thermal or chemical), diagnosed by the presence of clinical signs of total LSCD (in clock hours), including: 1.1. Loss of normal anatomy 1.2. Epithelial haze 1.3. Superficial subepithelial vascularisation 1.4. Persistent or recurrent epithelial defects 1.5. Epithelial and stromal inflammation 1.6. Fluorescein staining 1.7. Loss of limbal palisades of Vogt 2. Attending Cornea Services of Dr. R. P. Centre for Ophthalmic Sciences in New Delhi

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone prior intraocular/extraocular surgery 2. Bilateral involvement 3. Refuse to provide consent 4. Unavailable for follow up

Design outcomes

Primary

MeasureTime frame
The following are assessed at the baseline, and 3, 6, 12, 24 and 36 months after the operation: 1. Degree of inflammation, assessed using the grading score for inflammation (conjunctival hyperaemia) 2. Degree of corneal vascularisation, assessed using the grading score for corneal vascularisation—

Secondary

MeasureTime frame
The following are assessed at the baseline, and 3, 6, 12, 24 and 36 months after the operation: 1. Improvement in tear secretions, assessed using Schirmer's test 2. Ocular surface status, assessed using the overall grading for ocular surface parameters—

Countries

India

Outcome results

None listed

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