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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04319848
Other study ID # R1391/77/2016
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2017
Est. completion date February 2021

Study information

Verified date March 2020
Source Singapore Eye Research Institute
Contact Lee Yan Lim
Phone +65 6576 7322
Email lim.lee.yan@seri.com.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).


Description:

The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving Tissue-Engineered Endothelial keratoplasty (TE-EK) graft material generated from human corneal endothelial cells (HCEnCs) propagated in a regulatory-approved dual media approach. Post-operative follow-ups and visits will follow current EK protocols of Singapore National Eye Centre. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria:

Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including:

- Fuchs' endothelial dystrophy

- Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy

Exclusion Criteria:

- Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty

- Patients with complex anterior segment complications precluding a successful TE-EK procedure

- Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation

- Post-laser iridotomy or glaucoma related corneal decompensation

- Patients not keen to participate in the clinical trial

- Patients who are below 21 years of age or above 80 years of age

- Patients who are pregnant

- Patients who are cognitively impaired

- Patients who are prisoners

- Patients who are allergic to antibiotics

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TE-EK treatment group
Transplantation of tissue-engineered endothelial graft through DSAEK procedure.

Locations

Country Name City State
Singapore Singapore Eye Research Institute Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary (BSCVA) BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis. 3 months
Secondary Keratometric astigmatism and spherical equivalent Measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan) 3 months
Secondary Intraocular pressure measurement Measured by a noncontact tonometry (CT-60; Topcon) 3 Months
Secondary Endothelial cell density (ECD) Measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD. 3 months
Secondary Graft thickness Measured by ASOCT (Visante OCT, Carl Zeiss Meditec) 1 month
Secondary Contrast sensitivity Pentacam scatter 6 months
Secondary Postoperative complications Postoperative complications, such as graft dislocation, graft rejection, will be evaluated with slit lamp biomicroscopy. 1 month
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