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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450954
Other study ID # CRE-2013.687
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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