Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in… (NCT02568527) | Clinical Trial Compass
CompletedNot Applicable
Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients
India5 participantsStarted 2015-10
Plain-language summary
The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male and female participants who are ≥18 years of age.
✓. Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
✓. Participants having unilateral limbal stem cell deficiency due to chemical injury
✓. No prior history of limbal transplantation
✓. No ongoing and other active ocular pathology
✓. No severe pathological and psychological conditions that might interfere with the patients participation in the study
✓. Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.
Exclusion criteria
✕. Bilateral LSCD
✕. LSCD due to autoimmune disorders and partial LSCD
✕. Having other ongoing ocular pathologies and acute ocular inflammation
✕. Previous neoplastic/cancer disease
✕. Severe dry eyes confirmed by Schirmer's test
✕. Acute systemic infections
What they're measuring
1
Corneal Edema using Pachymetry
Timeframe: 12 months
2
Intraocular Pressure by Standard Applanation Tonometry
. Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
✕. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.