Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane fo… (NCT00799526) | Clinical Trial Compass
UnknownPhase 1
Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
10 participantsStarted 2008-11
Plain-language summary
The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon.
Who can participate
Age range
16 Years – 90 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:
* Patients with ocular surface disorders, e.g. symblepharon
* Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
* Only one eye of a patient will be eligible for study entry.
* Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
* Patients who are willing to undergo long-term follow-up, as outlined in this protocol
* Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
Exclusion Criteria:
* Patients less than 16 years of age
* Patients who are incapable, either by law or of mental state, of giving consent in their own right
* Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
* Patients who are pregnant or breastfeeding
* Patients with a history of drug allergy
* Patients who have received an investigational drug within 28 days preceding surgery
* Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
* Patients who are documented to be steroid responders
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
1
Reconstruction of Ocular surface in patients with symblepharon