ClinicalTrials.gg
Status unknownNCT03275896Updated Sep 8, 2017

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

An Early Phase 1 interventional study of Descemet Membrane Transplantation in Fuchs' Endothelial Dystrophy, sponsored by Singapore National Eye Centre. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Singapore National Eye Centre · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2016, registered Sep 2017).
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
21 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

Fuchs Endothelial Dystrophy (FED) is a degenerative disease affecting the corneal endothelium, characterized clinically by guttate excrescences on the posterior corneal surface and dysfunctional corneal endothelial cells. While patients are commonly asymptomatic in their early stages, advanced FED can be associated with significant corneal edema, scarring and impairment of visual function.

Patients with mild FED are usually managed conservatively with the application of topical hypertonic saline eyedrops. For patients with advanced FED, endothelial keratoplasty may often be necessary. In 2014, FED represented the most common indication for endothelial keratoplasty in the United States, accounting for 47.7% (13,817 cases) of all endothelial keratoplasty procedures performed nationwide. In Singapore, FED was the second most common indication for corneal transplantation.

Endothelial keratoplasty is associated with endothelial cell attrition in the range of 29.7% - 47% by the 3rd post-operative year. Additionally, the global demand for corneal graft material currently still far outstrips supply, critically limiting the number of patients who can potentially benefit from these surgical interventions. As such, there is a need explore alternative, sustainable strategies for the management of FED.

In 2009, Shah et al. reported the treatment of a 34 years old patient, with the combined pathologies of FED and Posterior Polymorphous Corneal Dystrophy (PPMD), by primary stripping of the central 4-5mm of Descemet's membrane without corneal graft transplantation ('Primary Descemetorhexis'). Contrary to conventional expectations, there was complete repopulation of the posterior corneal surface by corneal endothelial cells following the surgery, with best-corrected-visual-acuity (BCVA) of 6/7.5 achieved by the 6th post-operative month. In 2014, Moloney et al. published a similar report of a 54 years old patient, diagnosed with FED, successfully treated by Primary Descemetorhexis. Rapid endothelial recovery, as evidenced by a central endothelial cell count of 620 cells/mm2 and BCVA of 6/6, was achieved by approximately 6 weeks after the surgery. The success of these cases raised the prospect of Primary Descemetorhexis as a feasible alternative for the treatment of FED.

To gain a better understanding of the factors which may affect endothelial recovery following Primary Descemetorhexis, investigators performed an ex vivo human corneal endothelial cell culture experiment in which Primary Descemetorhexis was performed on cadaveric human cornea buttons, followed by ex vivo culture for a duration of 2 weeks to allow for endothelial recovery. A less invasive approach of denuding endothelial cells from the Descemet's membrane (DM), while maintaining anatomical integrity of the DM, was also assessed. The investigators found that advanced patient age and the absence of DM were significantly associated with slower endothelial recovery.

As such, the investigators hypothesized that the outcomes of Primary Descemetorhexis for the treatment of FED may be improved by DM transplantation following Primary Descemetorhexis ('DM Transplantation'). The main difference between the proposed technique of DM transplantation and conventional endothelial keratoplasty is that the DM transplant does not require the presence of a functional corneal endothelial monolayer on the graft. If successful, the greatest advantage of this approach would be to greatly expand the pool of donors who are eligible to provide cadaveric corneal graft tissue for transplantation.

02

Conditions studied

  • Fuchs' Endothelial Dystrophy
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 and not practising a medically approved method of , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Descemet Membrane Transplantation

    Patients with severe, symptomatic Fuch's Endothelial Dystrophy (FED) will be offered Descemet Membrane Transplantation (DMT) for their condition.

    Other: Descemet Membrane Transplantation

Interventions

  • OtherDescemet Membrane Transplantation

    The diseased host Descemet membrane will first be stripped, as per a standard Descemet Stripping Automated Endothelial Keratoplasty surgery. A cadaveric, acellular Descemet membrane graft will then be harvested and transplanted onto the host.

06

What researchers measure

Primary outcomes

  1. Central Endothelial Cell Density

    Central endothelial cell density will be determined using a specular microscope (Konan Medical), measured as number of cells per square millimetre, using the automated cell counting algorithm.

    Time frame: Measured monthly, for the first 6 post-operative months

Secondary outcomes

  1. Visual acuity

    The visual acuity will be measured using the Snellen visual acuity scale, performed in a standardized room using a 6-metre visual acuity lane, by a fully qualified optometrist.

    Time frame: Measured monthly, for the first 6 post-operative months

07

Study locations

1 of 1 sites recruiting
  • Singapore National Eye Centre
    Singapore, 168751, Singapore
    Recruiting
    • Yu Qiang Soh, MBBS · Contact
    • Jodhbir Mehta, FRCS · Principal investigator
08

References and documents

Publications

  • Soh YQ, Peh G, George BL, Seah XY, Primalani NK, Adnan K, Mehta JS. Predicative Factors for Corneal Endothelial Cell Migration. Invest Ophthalmol Vis Sci. 2016 Feb;57(2):338-48. doi: 10.1167/iovs.15-18300. PubMed 26842752 ↗
  • Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270. PubMed 25299425 ↗
  • Bleyen I, Saelens IE, van Dooren BT, van Rij G. Spontaneous corneal clearing after Descemet's stripping. Ophthalmology. 2013 Jan;120(1):215. doi: 10.1016/j.ophtha.2012.08.037. No abstract available. PubMed 23283191 ↗
  • Moloney G, Chan UT, Hamilton A, Zahidin AM, Grigg JR, Devasahayam RN. Descemetorhexis for Fuchs' dystrophy. Can J Ophthalmol. 2015 Feb;50(1):68-72. doi: 10.1016/j.jcjo.2014.10.014. Epub 2014 Oct 31. PubMed 25677286 ↗
  • Shah RD, Randleman JB, Grossniklaus HE. Spontaneous corneal clearing after Descemet's stripping without endothelial replacement. Ophthalmology. 2012 Feb;119(2):256-60. doi: 10.1016/j.ophtha.2011.07.032. Epub 2011 Oct 7. PubMed 21982414 ↗
  • Kitagawa K, Kojima M, Sasaki H, Shui YB, Chew SJ, Cheng HM, Ono M, Morikawa Y, Sasaki K. Prevalence of primary cornea guttata and morphology of corneal endothelium in aging Japanese and Singaporean subjects. Ophthalmic Res. 2002 May-Jun;34(3):135-8. doi: 10.1159/000063656. PubMed 12097795 ↗
  • 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. PubMed 34633355 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — No sharing of OPD with other researchers

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2016 (actual). Primary completion is estimated for Dec 2020, 51 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2017
First posted
Sep 8, 2017
StartActual
Sep 2016
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2020
Last update
Sep 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03275896
Lead sponsor
Singapore National Eye Centre
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Sep 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Sep 8, 2017

Study contacts

Yu Qiang Soh, MBBS
Contact
yuqiang.soh@mohh.com.sg
Jodhbir Mehta, FRCS
principal investigator · Singapore National Eye Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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