CompletedPhase 1

The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)

10 participantsStarted 2011-08

Plain-language summary

Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation. This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).

Who can participate

Age range

18 Years – 50 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: * Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua. * Without Age limitation Exclusion Criteria: * Lack of timely referral of patients for examinations * Simultaneous use of other drugs that cause impairment of the data

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

Limbal defect size

Timeframe: 12 months

Corneal epithelial integrity

Timeframe: 12 months

Corneal epithelial stability

Timeframe: 12 months

Trial details

NCT IDNCT02649621

SponsorRoyan Institute

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency (LSCD) trials

Plain-language summary

Who can participate

Age range

18 Years – 50 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.