Corneal Epithelial DefectNCT00238862
Treatment of PED With AMT and Autologous Serum
A study testing Amniotic membrane transplantation and Autologous serum/BSS 20% in people with Corneal Epithelial Defect, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Epithelial Defect
- What is being tested?
- Amniotic membrane transplantation and Autologous serum/BSS 20%
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Oct 2005to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal epithelial defect of more than 14 days that has not responded to conventional therapy
Who cannot join
- Under age 18
- Pregnant/lactating females
- Patients with hemoglobin levels < 12 mg/ml
- Patients with limbal stem cell deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.
- Conditions
- Corneal Epithelial Defect
- Being tested
- Amniotic membrane transplantation, Autologous serum/BSS 20%
- Keywords
- Diabetes, Corneal transplant, Neurotrophic keratitis, Post-bacterial keratitis, Metaherpetic keratitis
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane transplantationProcedure or surgery
Autologous serum/BSS 20%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal re-epithelialization (= initial success)
Persistent corneal re-epithelialization (= lasting success)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startOct 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael D Wagoner, MD, Principal investigator, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238862
- Sponsor's protocol ID
- RP0511-P
- Status last verified
- Nov 2021
- First submitted
- 12 Oct 2005
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects
- ClinicalTrials.gov ID
- NCT00238862
- Acronym / sponsor ID
- RP0511-P
- Conditions
- Corneal Epithelial Defect
- Keywords
- Diabetes, Corneal transplant, Neurotrophic keratitis, Post-bacterial keratitis, Metaherpetic keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Oct 2005
- Study completion
- Sep 2006
- First posted
- 14 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Corneal epithelial defect of more than 14 days that has not responded to conventional therapy
Key exclusion criteria (4 listed)
- Under age 18
- Pregnant/lactating females
- Patients with hemoglobin levels < 12 mg/ml
- Patients with limbal stem cell deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic membrane transplantation | Procedure or surgery | – |
| Autologous serum/BSS 20% | Drug | – |
Primary outcome
Corneal re-epithelialization (= initial success)
Persistent corneal re-epithelialization (= lasting success)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Wagoner, MD principal investigator
King Khaled Eye Specialist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane transplantation and Autologous serum/BSS 20% in people with Corneal Epithelial Defect, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal re-epithelialization (= initial success). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.