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Unknown statusEarly Phase 1

Evaluation of the Efficacy of Descemet Membrane Transplantation for the Treatment of Fuchs' Endothelial Dystrophy

NCT03275896 · Singapore National Eye Centre

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Fuchs Endothelial Dystrophy (FED) is a degenerative disease affecting the corneal endothelium. The current gold-standard for treatment of severe FED is endothelial keratoplasty, wherein a cadaveric Descemet's membrane / endothelium graft is transplanted. In this study, the investigators hypothesized that the transplantation of an acellular Descemet's membrane (i.e. Descemet Membrane Transplantation, 'DMT') may be equally efficacious in promoting recovery of endothelial function in this group of patients.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Central Endothelial Cell Density

    Measured over Measured monthly, for the first 6 post-operative months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 85 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Fuchs' Endothelial Dystrophy (FED) as defined by any of the following criteria: 1. FED of at least Grade 4 on the Krachmer grading scale (i.e. greater than 5mm of confluent central corneal guttata) 2. Best-corrected-visual-acuity of less than 6/12 in a patient clinically diagnosed with FED of any grade, in which poor visual acuity cannot be accounted by any other significant ophthalmic disease (e.g. cataracts, age-related macular degeneration, glaucoma, optic neuropathies) 2. Patients in the range of \<85 years old will be recruited for this study 3. Only individuals with the mental capacity to provide informed consent will be included. 4. Patients who are willing and able to sign a written Informed Consent Form prior to any study-specific procedures will be included 5. Patients who are willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery will be included Exclusion Criteria: Subjects that meet any of the following criteria will be excluded from participation: 1. Eyes which have previously been subject to any form of keratoplasty 2. An only-functioning eye in a patient who has lost visual potential in the contralateral eye 3. Patients with chronic, advanced FED who meet the above mentioned inclusion criteria, but whose disease is associated with significant stromal scarring to such an extent that will predictably impair post-operative visual recovery after DSAEK or DM transplant 4. Patients whose corneal endothelial disease may possibly be attributed to pathologies other than FED, including but not limited to pseudophakic bullous keratopathy, laser-peripheral-iridotomy induced bullous keratopathy, iridocorneal endothelial syndrome, Axenfeld Rieger syndrome, congenital hereditary endothelial dystrophy and any other anterior segment developmental anomalies 5. Patients with visually significant cataracts 6. Patients with diagnosed with visually significant retinal disease, including but not limited to age-related macular degeneration, myopic macular degeneration, diabetic retinopathy, diabetes related maculopathy, retinal vein occlusion related maculpathy, retinal dystrophies and previous retinal detachments. 7. Patients with any form of glaucoma 8. Patients diagnosed with visually significant, non-glaucomatous optic neuropathies, including but not limited to those related to ischemic (both arteritic and non-arteritic), toxic, nutritional, myopic, compression, infective and inflammatory causes 9. Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.

Where

1 study site

FacilityCityRegionCountry
Singapore National Eye CentreSingaporeSingapore

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT03275896 on ClinicalTrials.gov →

Last updated in the registry 2017-09-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance