Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

Bullous Keratopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450954
• Other study ID #: CRE-2013.687
• Status: Completed
• Phase: N/A
• First received: February 23, 2018
• Last updated: March 1, 2018
• Start date: October 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2018
• Source: Prince of Wales Hospital, Shatin, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bullous Keratopathy
• Corneal Edema

Intervention

Procedure:
• Amniotic membrane transplant
Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Wales Hospital, Shatin, Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic membrane retention	Amniotic membrane retention in the cornea was assessed with confocal microscopy	from date of operation till 2016
Secondary	Pain	pain score (from 0-10, scale interval 1, 0 no pain, 10 most painful)reduction after amniotic membrane tranplant	from date of operation till 2016