An observational study in Bullous Keratopathy, sponsored by Singapore Eye Research Institute. Completed at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Singapore Eye Research Institute · Observational
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.
Singapore Eye Research Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
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Patients with Bullous Keratopathy
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.
Exclusion Criteria:
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 Graft Failure
Time frame: One month
Donor Graft Dislocation
Time frame: One week
Endothelial Cell loss
Time frame: One year
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Singapore Eye Research Institute