Clinical trial NCT04319848: Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Official title: Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mild to Moderate Corneal Endothelial Decompensation
Bullous Keratopathy
Fuchs' Endothelial Dystrophy
Post-surgical Corneal Decompensation (Irreversible)
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: (BSCVA)
timeFrame: 3 months
Secondary outcomes:
measure: Keratometric astigmatism and spherical equivalent
timeFrame: 3 months
measure: Intraocular pressure measurement
timeFrame: 3 Months
measure: Endothelial cell density (ECD)
timeFrame: 3 months
measure: Graft thickness
timeFrame: 1 month
measure: Contrast sensitivity
timeFrame: 6 months
measure: Postoperative complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Jodhbir Mehta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soh YQ, Poh SSJ, Peh GSL, Mehta JS. New Therapies for Corneal Endothelial Diseases: 2020 and Beyond. Cornea. 2021 Nov 1;40(11):1365-1373. doi: 10.1097/ICO.0000000000002687.