Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSingapore Eye Research Institute
About this trial
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
Patients with complex anterior segment complications precluding a successful SNEC-I 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
Trial design
Design model
Single group
Treatments tested in this trial
Cell injection
Biological/VaccineDirect endothelial cell injection of non-cultured corneal endothelial cells
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
BSCVA
Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.
Time frame
1, 3, 6, 12 months post-operativelySecondary outcomes
1
Autokeratorefractometer
Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Time frame
1, 3, 6, and 12 months post-operatively2
Intraocular pressure
Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)
Time frame
1, 3, 6 and 12 months post-operatively3
Endothelial Cell Density
Endothelial cell density (ECD): will be 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
Time frame
1, 3, 6 and 12 months post-operatively4
Graft thickness
Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Time frame
1, 3, 6 and 12 months post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Singapore Eye Research Institute
Lead sponsor
L.V. Prasad Eye Institute
Collaborator
Source ClinicalTrials.gov