NCT03450954

Brief 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. Comparison was made with 5 controls who had bullous keratopathy awaiting endothelial keratoplasty.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 23, 2018

Last Update Submit

March 1, 2018

Conditions

Bullous Keratopathy

Outcome Measures

Primary Outcomes (1)

  • Amniotic membrane retention

    Amniotic membrane retention in the cornea was assessed with confocal microscopy

    from date of operation till 2016

Secondary Outcomes (1)

  • Pain

    from date of operation till 2016

Study Arms (2)

Case(AMT patients)

patients who have undergone amniotic membrane transplant in our unit up till 2016.

Procedure: Amniotic membrane transplant

Control(Patients without AMT)

bullous keratopathy patients awaiting endothelial keratoplasty

Interventions

Amniotic membrane transplantPROCEDURE

Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique

Case(AMT patients)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gillian DJ Siu, MBChB

    The Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Specialist

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

October 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

March 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share