The SNEC DSAEK EndoGlide Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Bullous Keratopathy
• Intervention / Treatment: Device: Endoglide

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Bullous Keratopathy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Graft Failure	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
Donor Graft Dislocation	One week
Endothelial Cell loss	One year

Collaborators and Investigators

• Sponsor: Singapore Eye Research Institute
• Collaborators: UK Network Medical
• Investigators: Principal Investigator: Donald Tan, MD FRCS, Singapore National Eye Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Corneal Transplant; DSAEK; Endothelial Keratoplasty; Endoglide; Donor Insertion; Patients with Bullous Keratopathy
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Corneal Edema
• Other Study ID Numbers: R664/14/2009; Other grant (Other Grant/Funding Number: NMRC/TCR/002 - SERI/2008 - TCR 621/41/2008])