Advertisement

Topics

The SNEC DSAEK EndoGlide Clinical Trial

2014-07-23 21:09:06 | BioPortfolio

Summary

The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the Endoglide will cause less endothelial damage compared to the investigators previous technique of glide insertion but will have the same low complication rate as the previous device. Hence the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch. Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound. Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms of postoperative visual acuity, primary graft failure rate, donor dislocation rate, endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal patients referred to the SNEC Corneal Clinics of the study investigators with moderate degrees of corneal decompensation from a variety of disorders which require DSAEK corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Bullous Keratopathy

Intervention

Endoglide

Location

Singapore National Eye Centre
Singapore
Singapore
168751

Status

Recruiting

Source

Singapore Eye Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:06-0400

Clinical Trials [38 Associated Clinical Trials listed on BioPortfolio]

Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography ...

Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy

The purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

Register of Autoimmune Bullous Dermatoses

Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-...

Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients

Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease

Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus

to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.

PubMed Articles [87 Associated PubMed Articles listed on BioPortfolio]

Injection of Cultured Cells with a ROCK Inhibitor for Bullous Keratopathy.

Corneal endothelial cell (CEC) disorders, such as Fuchs's endothelial corneal dystrophy, induce abnormal corneal hydration and result in corneal haziness and vision loss known as bullous keratopathy. ...

Bilateral bullous keratopathy secondary to melting keratitis in a Suri alpaca ().

An young alpaca was evaluated for bilateral progressive melting corneal ulcers and developped secondary bullous keratopathy during hospitalization. The tragic progression of melting ulcers in both eye...

Cultured Cells and ROCK Inhibitor for Bullous Keratopathy.

Cancer is not a risk factor for bullous pemphigoid. A ten-year population-based cohort study.

Bullous pemphigoid (BP) is the most common autoimmune bullous disease. Whether there is an increased risk for subsequent BP among cancer patients is still unclear.

Bullous pemphigoid with hyperkeratosis and palmoplantar keratoderma: Three cases.

The clinical features of bullous pemphigoid are extremely polymorphous. Several atypical forms of bullous pemphigoid have been described, and the diagnosis critically relies on immunopathological find...

Medical and Biotech [MESH] Definitions

An itching, autoimmune, bullous SKIN disease that occurs during the last two trimesters of PREGNANCY and PUERPERIUM. It also affects non-pregnant females with tissue of PLACENTA origin, such as CHORIOCARCINOMA; or HYDATIDIFORM MOLE. It exhibits antigenic and clinical similarity to bullous pemphigoid (PEMPHIGOID, BULLOUS). This disease does not involve herpes viruses (old name, herpes gestationis).

Designation for several severe forms of ichthyosis, present at birth, that are characterized by hyperkeratotic scaling. Infants may be born encased in a collodion membrane which begins shedding within 24 hours. This is followed in about two weeks by persistent generalized scaling. The forms include bullous (HYPERKERATOSIS, EPIDERMOLYTIC), non-bullous (ICHTHYOSIS, LAMELLAR), wet type, and dry type.

A chronic and relatively benign subepidermal blistering disease usually of the elderly and without histopathologic acantholysis.

A vesicular and bullous eruption having a tendency to recur in summer during childhood and commonly appearing on sun-exposed skin. The lesions are surrounded by an erythematous zone and resemble a vaccination. (From Dorland, 27th ed)

A variant of bullous erythema multiforme. It ranges from mild skin and mucous membrane lesions to a severe, sometimes fatal systemic disorder. Ocular symptoms include ulcerative conjunctivitis, keratitis, iritis, uveitis, and sometimes blindness. The cause of the disease is unknown.

More From BioPortfolio on "The SNEC DSAEK EndoGlide Clinical Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...


Searches Linking to this Trial