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The SNEC DSAEK EndoGlide Clinical Trial

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ClinicalTrials.gov Identifier: NCT01122043
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : July 20, 2016
Sponsor:
Collaborator:
UK Network Medical
Information provided by (Responsible Party):
Jodhbir Mehta, Singapore Eye Research Institute

Brief 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.

Condition or disease Intervention/treatment
Bullous Keratopathy Device: Endoglide

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The SNEC DSAEK EndoGlide Clinical Trial
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2013

Group/Cohort Intervention/treatment
Endoglide
Patients 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.
Device: Endoglide
Device




Primary Outcome Measures :
  1. Primary Graft Failure [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Donor Graft Dislocation [ Time Frame: One week ]
  2. Endothelial Cell loss [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Bullous Keratopathy
Criteria

Inclusion Criteria:

  1. patients presenting with corneal decompensation or bullous keratopathy requiring corneal transplantation for visual restoration and pain relief
  2. Clinical diagnoses including post-surgical forms of corneal decompensation (all forms of pseudophakic and aphakic bullous keratopathy including TASS and irreversible Descemets detachment), post-laser corneal decompensation, Fuchs' and other forms of endothelial dystrophy, traumatic corneal decompensation, post-inflammatory corneal decompensation, etc.
  3. Mild to moderate forms of corneal decompensation
  4. patients who agree to study participation following full informed consent
  5. patients who agree to adhere to the standard SNEC clinical DSAEK protocol in terms of pre and postoperative investigations and follow-up visits up to 12 months

Exclusion Criteria:

  1. Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for DSAEK surgery as apposed to penetrating keratoplasty
  2. patients with complex anterior segment complications precluding a successful DSAEK procedure
  3. patients unkeen to participate in the clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122043


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore Eye Research Institute
UK Network Medical
Investigators
Principal Investigator: Donald Tan, MD FRCS Singapore National Eye Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jodhbir Mehta, Head Tissue Engineering and Stem Cell Group, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT01122043     History of Changes
Other Study ID Numbers: R664/14/2009
Other grant ( Other Grant/Funding Number: NMRC/TCR/002 - SERI/2008 - TCR 621/41/2008] )
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Jodhbir Mehta, Singapore Eye Research Institute:
Endoglide
Endothelial Keratoplasty
Donor Insertion
DSAEK
Corneal Transplant
Patients with Bullous Keratopathy

Additional relevant MeSH terms:
Corneal Edema
Corneal Diseases
Eye Diseases