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Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03450954
Enrollment
27
Registered
2018-03-01
Start date
2016-10-01
Completion date
2016-11-30
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous Keratopathy

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.

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.

Interventions

PROCEDUREAmniotic membrane transplant

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

Sponsors

Prince of Wales Hospital, Shatin, Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amniotic membrane retentionfrom date of operation till 2016Amniotic membrane retention in the cornea was assessed with confocal microscopy

Secondary

MeasureTime frameDescription
Painfrom date of operation till 2016pain score (from 0-10, scale interval 1, 0 no pain, 10 most painful)reduction after amniotic membrane tranplant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026