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CompletedNCT03450954Updated Mar 2, 2018

Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

An observational study in Bullous Keratopathy, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Completed. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
27
Sex
All
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Study 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.

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.

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Conditions studied

  • Bullous Keratopathy

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureAmniotic membrane transplant

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

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What researchers measure

Primary outcomes

  1. Amniotic membrane retention

    Amniotic membrane retention in the cornea was assessed with confocal microscopy

    Time frame: 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

    Time frame: from date of operation till 2016

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03450954
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Responsible party
Gillian Siu (Resident Specialist, Prince of Wales Hospital, Shatin, Hong Kong) — Principal investigator
First posted
Mar 1, 2018
Start date
Oct 1, 2016
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016
Last update
Mar 2, 2018

Study contacts

Gillian DJ Siu, MBChB
principal investigator · The Prince of Wales Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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