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Completed

NCT Number: NCT03450954

Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

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.

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Key information

Conditions

Bullous Keratopathy

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amniotic membrane transplant

Procedure

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

Primary outcomes

  1. Amniotic membrane retention

    Time frame: from date of operation till 2016

    Amniotic membrane retention in the cornea was assessed with confocal microscopy

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Registry information

Official study title

Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2018
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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