Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

NCT ID: NCT03450954

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Bullous Keratopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case(AMT patients)

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

Amniotic membrane transplant

Intervention Type PROCEDURE

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

Control(Patients without AMT)

bullous keratopathy patients awaiting endothelial keratoplasty

No interventions assigned to this group

Interventions

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Amniotic membrane transplant

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Gillian Siu

Resident Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gillian DJ Siu, MBChB

Role: PRINCIPAL_INVESTIGATOR

The Prince of Wales Hospital

Other Identifiers

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CRE-2013.687

Identifier Type: -

Identifier Source: org_study_id

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