The SNEC DSAEK EndoGlide Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01122043
Study type	Observational
Source	Singapore Eye Research Institute
Contact
Status	Completed
Phase	N/A
Start date	January 2010
Completion date	January 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03248037` - Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation	Phase 3
Enrolling by invitation	`NCT05956535` - Air Optix® Night and Day® Aqua Therapeutic Wear
Recruiting	`NCT02020044` - Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)	N/A
Recruiting	`NCT03407755` - Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)	N/A
Completed	`NCT01448213` - Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)	Phase 2
Completed	`NCT03450954` - Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients	N/A
Completed	`NCT01926535` - Amniotic Membrane Graft In Syntomathic Bullous Keratopathy	Phase 2
Completed	`NCT01106274` - The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy	N/A
Completed	`NCT03763721` - The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation	N/A
Completed	`NCT05891106` - AONDA Therapeutic Indication Study I
Active, not recruiting	`NCT04894110` - Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema	Phase 1
Completed	`NCT00659308` - Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy	N/A
Completed	`NCT00800111` - Study of Endothelial Keratoplasty Outcomes	N/A
Recruiting	`NCT05636579` - Study to Assess Safety and Tolerability of Multiple Doses of EO2002	Phase 1
Recruiting	`NCT04319848` - Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty	Phase 1
Recruiting	`NCT05436665` - The Belgian Endothelial Surgical Transplant of the Cornea	N/A
Not yet recruiting	`NCT02736877` - Corneal Transplantation Guided by OCT RESCAN	N/A