Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01122043
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2010-05-10
Brief Title:
The SNEC DSAEK EndoGlide Clinical Trial
Sponsor:
Singapore Eye Research Institute
Organization:
Singapore Eye Research Institute
Study Overview
Official Title:
The SNEC DSAEK EndoGlide Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45mm 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Other grant | OTHER_GRANT | NMRCTCR002 - SERI2008 - TCR 621412008 | None |