Eye BurnsPhase 2/3NCT00370812
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
A Phase 2/3 study testing amniotic membrane transplantation in people with Eye Burns, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Burns
- What is being tested?
- amniotic membrane transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jul 2006to Jan 2009
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chemical eye burn grade 2-4
- Burning has been occurred in 2 weeks
Who cannot join
- Grade I burnings
- More than 2 weeks have passed of burning
- Follow up of the patients has been disconnected in 6 month
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad Medical Center
Tehran, Tehran Province, 16666
Alireza Baradaran Rafiee, MD, +98 21 22587317, labbafi@hotmail.com
Alireza Baradaran Rafiee, MD
About this study
This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.
Read the detailed description
The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury.
After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either AMT with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. AMT will be performed within 24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain (subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal vascularization and opacity, and symblepharon formation will be assessed. Digital photographs at each visit will be obtained.
- Conditions
- Eye Burns
- Being tested
- amniotic membrane transplantation
- Keywords
- amniotic membrane transplantation, ocular chemical burns
- Medical subject headings
- Eye Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic membrane transplantationProcedure or surgery
AMT with conventional medical therapy (group A) or medical treatment only (group B). AMT will be performed within 24h of presentation. Amniotic membrane will remain in place for 7-14 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | AMT with conventional medical therapy Receives: Procedure: amniotic membrane transplantation |
| B | Active comparator | Medical treatment alone Receives: Procedure: amniotic membrane transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Pain
Measured: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Symblepharon formation
Measured: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Epithelial defect healing
Measured: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Corneal opacity and vascularization
Measured: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye BurnsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Alireza Baradaran Raffiee, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370812
- Sponsor's protocol ID
- 8528
- Status last verified
- Sep 2008
- First submitted
- 31 Aug 2006
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
- ClinicalTrials.gov ID
- NCT00370812
- Acronym / sponsor ID
- 8528
- Conditions
- Eye Burns
- Keywords
- amniotic membrane transplantation, ocular chemical burns
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 1 Sep 2006 (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.
This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.
Detailed description
The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury.
After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either AMT with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. AMT will be performed within 24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain (subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal vascularization and opacity, and symblepharon formation will be assessed. Digital photographs at each visit will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: amniotic membrane transplantationAMT with conventional medical therapy |
| B | Active comparator | Procedure: amniotic membrane transplantationMedical treatment alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chemical eye burn grade 2-4
- Burning has been occurred in 2 weeks
Key exclusion criteria (3 listed)
- Grade I burnings
- More than 2 weeks have passed of burning
- Follow up of the patients has been disconnected in 6 month
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 transplantationAMT with conventional medical therapy (group A) or medical treatment only (group B). AMT will be performed within 24h of presentation. Amniotic membrane will remain in place for 7-14 days. | Procedure or surgery | A, B |
Primary outcome
Visual acuity
Time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Pain
Time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Symblepharon formation
Time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Epithelial defect healing
Time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Corneal opacity and vascularization
Time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
Related trials for Eye Burns
RecruitingObservational study
OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in Retinal Photo-injury
Retinal Light Damage, Photic Retinopathy
Recruiting
Vit-A-Vision® Clinical Investigation
Burning Eye, Irritation; Eyeball
Not yet recruitingPhase 2
Treatment of Severe Ocular Chemical Burns by Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells: An Open-Label, Single-Arm, Multicenter Phase II Trial
Chemical Burns, Ocular Burns
Recruiting
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
Macular Degeneration, Senile, Laser Burn of Retina
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.
Alireza Baradaran Raffiee, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing amniotic membrane transplantation in people with Eye Burns, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 2008. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alireza Baradaran Raffiee, MD (+98 21 22587317, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year). The study lists 5 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 25 Sep 2008.