Bullous KeratopathyNCT03450954
Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients
An observational study of Bullous Keratopathy, run by Prince of Wales Hospital, Shatin, Hong Kong.
Trial summary
A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect any corneal structural changes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bullous Keratopathy
- What is being tested?
- Amniotic membrane transplant
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Nov 2016
- Phase
- Observational
- 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
Study population: Cases who have undergone amniotic membrane transplant in our unit up till 2016 and controls who had bullous keratopathy awaiting endothelial keratoplasty
Who may be able to join
- All patients who have undergone amniotic membrane transplant in our cluster up till 2016.
- Patients who have bullous keratopathy on conservative treatment such as lubricants, bandage contact lens
Who cannot join
- patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.
About this study
Official title: Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results
A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect any corneal structural changes. Comparison was made with 5 controls who had bullous keratopathy awaiting endothelial keratoplasty.
Read the detailed description
This retrospective cohort study (CREC Ref No.: CRE-2013.687) was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee. All patients who had AMT done due to symptomatic bullous keratopathy at the Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital (from 1998 onwards till June 2016) were invited back for confocal microscopy and anterior segment optical coherence tomography (ASOCT) at the clinic by the principal investigator (GS) from October to November 2016.
- Conditions
- Bullous Keratopathy
- Being tested
- Amniotic membrane transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane transplantProcedure or surgery
Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique
| Study group | Role | What they receive |
|---|---|---|
| Case(AMT patients) | patients who have undergone amniotic membrane transplant in our unit up till 2016. Receives: Procedure: Amniotic membrane transplant | |
| Control(Patients without AMT) | bullous keratopathy patients awaiting endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amniotic membrane retention
Amniotic membrane retention in the cornea was assessed with confocal microscopy
Measured: from date of operation till 2016
Secondary outcomes (1)
Pain
pain score (from 0-10, scale interval 1, 0 no pain, 10 most painful)reduction after amniotic membrane tranplant
Measured: from date of operation till 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Oct 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous KeratopathyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Siu, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Gillian DJ Siu, MBChB, Principal investigator, The Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450954
- Sponsor's protocol ID
- CRE-2013.687
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results
- ClinicalTrials.gov ID
- NCT03450954
- Acronym / sponsor ID
- CRE-2013.687
- Conditions
- Bullous Keratopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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.
A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect any corneal structural changes. Comparison was made with 5 controls who had bullous keratopathy awaiting endothelial keratoplasty.
Detailed description
This retrospective cohort study (CREC Ref No.: CRE-2013.687) was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee. All patients who had AMT done due to symptomatic bullous keratopathy at the Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital (from 1998 onwards till June 2016) were invited back for confocal microscopy and anterior segment optical coherence tomography (ASOCT) at the clinic by the principal investigator (GS) from October to November 2016.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case(AMT patients) | – | Procedure: Amniotic membrane transplantpatients who have undergone amniotic membrane transplant in our unit up till 2016. |
| Control(Patients without AMT) | – | –bullous keratopathy patients awaiting endothelial keratoplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases who have undergone amniotic membrane transplant in our unit up till 2016 and controls who had bullous keratopathy awaiting endothelial keratoplasty
Key inclusion criteria (2 listed)
- All patients who have undergone amniotic membrane transplant in our cluster up till 2016.
- Patients who have bullous keratopathy on conservative treatment such as lubricants, bandage contact lens
Key exclusion criteria (1 listed)
- patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.
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 transplantAmniotic membrane graft was transplanted onto the bullous cornea by the inlay technique | Procedure or surgery | Case(AMT patients) |
Primary outcome
Amniotic membrane retention
Time frame: from date of operation till 2016
Amniotic membrane retention in the cornea was assessed with confocal microscopy
1 secondary outcome
Pain
Time frame: from date of operation till 2016
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 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Gillian DJ Siu, MBChB principal investigator
The Prince of Wales Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Keratopathy, run by Prince of Wales Hospital, Shatin, Hong Kong.
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 1 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Amniotic membrane retention (time frame: from date of operation till 2016). 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 Mar 2018.