Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT03450954
• Collaborator: (none)
• Enrollment: 27
• Actual Duration (Months): 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bullous Keratopathy	Procedure: Amniotic membrane transplant

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 Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Nov 30, 2016
• Actual Study Completion Date: Nov 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Case(AMT patients) patients who have undergone amniotic membrane transplant in our unit up till 2016.	Procedure: Amniotic membrane transplant; Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique
Control(Patients without AMT) bullous keratopathy patients awaiting endothelial keratoplasty

Outcome Measures

Primary Outcome Measures

1. Amniotic membrane retention [from date of operation till 2016]

   Amniotic membrane retention in the cornea was assessed with confocal microscopy

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients who have undergone amniotic membrane transplant in our cluster up till

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong

Investigators

• Principal Investigator: Gillian DJ Siu, MBChB, The Prince of Wales Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gillian Siu, Resident Specialist, Prince of Wales Hospital, Shatin, Hong Kong
• ClinicalTrials.gov Identifier: NCT03450954
• Other Study ID Numbers: CRE-2013.687
• First Posted: Mar 1, 2018
• Last Update Posted: Mar 2, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Corneal Edema

Study Results

No Results Posted as of Mar 2, 2018