The SNEC DSAEK EndoGlide Clinical Trial

NCT01122043 | Completed

• 2 other identifiers: R664/14/2009Other grant
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bullous Keratopathy

Keywords

Endoglide; Endothelial Keratoplasty; Donor Insertion; DSAEK; Corneal Transplant; Patients with Bullous Keratopathy

Outcome Measures

Primary Outcomes (1)

• Primary Graft Failure

  One month

Secondary Outcomes (2)

• Donor Graft Dislocation

  One week

• Endothelial Cell loss

  One year

Study Arms (1)

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

Interventions

Endoglide DEVICE

Device

Endoglide

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Bullous Keratopathy

You may qualify if:

• patients presenting with corneal decompensation or bullous keratopathy requiring corneal transplantation for visual restoration and pain relief
• 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.
• Mild to moderate forms of corneal decompensation
• patients who agree to study participation following full informed consent
• 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

You may not qualify if:

• Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for DSAEK surgery as apposed to penetrating keratoplasty
• patients with complex anterior segment complications precluding a successful DSAEK procedure
• patients unkeen to participate in the clinical trial

Sponsors & Collaborators

• Singapore Eye Research Institute: lead
• UK Network Medical: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Related Publications (1)

• 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.

  PMID: 21168813 DERIVED

Study Officials

• Donald Tan, MD FRCS

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Tissue Engineering and Stem Cell Group

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

SG (1)