Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients
March 1, 2018 updated by: Gillian Siu, Prince of Wales Hospital, Shatin, Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
27
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cases who have undergone amniotic membrane transplant in our unit up till 2016 and controls who had bullous keratopathy awaiting endothelial keratoplasty
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Case(AMT patients)
patients who have undergone amniotic membrane transplant in our unit up till 2016.
|
Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique
|
|
Control(Patients without AMT)
bullous keratopathy patients awaiting endothelial keratoplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amniotic membrane retention
Time Frame: from date of operation till 2016
|
Amniotic membrane retention in the cornea was assessed with confocal microscopy
|
from date of operation till 2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: from date of operation till 2016
|
pain score (from 0-10, scale interval 1, 0 no pain, 10 most painful)reduction after amniotic membrane tranplant
|
from date of operation till 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gillian DJ Siu, MBChB, The Prince of Wales Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
February 23, 2018
First Posted (Actual)
March 1, 2018
Study Record Updates
Last Update Posted (Actual)
March 2, 2018
Last Update Submitted That Met QC Criteria
March 1, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2013.687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.