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| ID | Type | Description | Link |
|---|---|---|---|
| Other grant | Other Grant/Funding Number | NMRC/TCR/002 - SERI/2008 - TCR 621/41/2008] |
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| Name | Class |
|---|---|
| UK Network Medical | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoglide | Device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Graft Failure | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Donor Graft Dislocation | One week | |
| Endothelial Cell loss | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Bullous Keratopathy
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| Name | Affiliation | Role |
|---|---|---|
| Donald Tan, MD FRCS | Singapore National Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | 168751 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21168813 | Derived | Khor WB, Mehta JS, Tan DT. Descemet stripping automated endothelial keratoplasty with a graft insertion device: surgical technique and early clinical results. Am J Ophthalmol. 2011 Feb;151(2):223-32.e2. doi: 10.1016/j.ajo.2010.08.027. Epub 2010 Dec 18. |
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