Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

Completed

• Conditions: Bullous Keratopathy
• Interventions: Procedure: Amniotic membrane transplant

• Registration Number: NCT03450954
• Lead Sponsor: Prince of Wales Hospital, Shatin, Hong Kong

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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-02-23
• Status Verified: 2018-03
• Study First Posted: 2018-03-01
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case(AMT patients)	Amniotic membrane transplant	patients who have undergone amniotic membrane transplant in our unit up till 2016.

Primary Outcome Measures

Name	Time	Method
Amniotic membrane retention	from date of operation till 2016	Amniotic membrane retention in the cornea was assessed with confocal microscopy

Secondary Outcome Measures

Name	Time	Method
Pain	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