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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Corneal Edema using Pachymetry

Timeframe: 12 months

Intraocular Pressure by Standard Applanation Tonometry

Timeframe: 12 months

Ocular Pain

Timeframe: 12 months

Schirmer's test (5 minute) without anesthesia

Timeframe: 12 months

Clinical Laboratory Adverse Events

Timeframe: 12 months

Vital Signs

Timeframe: 12 months

Trial details

NCT IDNCT02568527

SponsorVirender S Sangwan, MBBS, MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Corneal Edema using Pachymetry

Timeframe: 12 months

Intraocular Pressure by Standard Applanation Tonometry

Timeframe: 12 months

Ocular Pain

Timeframe: 12 months

Schirmer's test (5 minute) without anesthesia

Timeframe: 12 months

Clinical Laboratory Adverse Events

Timeframe: 12 months

Vital Signs

Timeframe: 12 months

Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria