Endothelial Lamellar Keratoplasty (ELK) with Tisseel adhesive. - ELK with Tisseel.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002389-13-GB

Enrollment

Registered

2005-10-24

Start date

2005-11-23

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal endothelial failure, from Fuchs' corneal endothelial dystrophy, aphakic and pseudophakic bullous keratopathy and other causes.

Interventions

Trade Name: TISSEEL KIT Two-Component Fibrin Sealant Product Name: TISSEEL KIT Product Code: TISSEEL Pharmaceutical Form: Powder and solvent for sealant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with corneal endothelial failure but without significant corneal stromal scarring. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients known to be hypersensitive to Tisseel adhesive, or aprotinin. Pregnant women.

Design outcomes

Primary

Measure	Time frame
Main Objective: When corneal endothelial lamellar keratoplasty is carried out using a simple Descemetectomy technique, in the applicant's experience a high proportion of grafts become dislocated in the early post-operative stage, and require repositioning. This study sets out to establish if the use of Tisseel adhesive applied to the graft at the time of insertion will lead to better graft stability, and improved graft outcome. ; Secondary Objective: To establish if any adverse effects arise as a result of the use of Tisseel, and to see if this technique, by simplifying the surgical procedure and reducing tissue manipulation, causes less tissue damage, and gives improved corneal endothelial cell survival. ;Primary end point(s): Rate of graft dislocation. Proportion of grafts becoming clear. The difference between the pre-operative and post-operative uncorrected visual acuity, best corrected visual acuity, and refraction. Patient's corneal topographic profile. Corneal endothelial cell count on graft. Rates of graft rejection.	—

Measure

Time frame

Main Objective: When corneal endothelial lamellar keratoplasty is carried out using a simple Descemetectomy technique, in the applicant's experience a high proportion of grafts become dislocated in the early post-operative stage, and require repositioning. This study sets out to establish if the use of Tisseel adhesive applied to the graft at the time of insertion will lead to better graft stability, and improved graft outcome. ; Secondary Objective: To establish if any adverse effects arise as a result of the use of Tisseel, and to see if this technique, by simplifying the surgical procedure and reducing tissue manipulation, causes less tissue damage, and gives improved corneal endothelial cell survival. ;Primary end point(s): Rate of graft dislocation. Proportion of grafts becoming clear. The difference between the pre-operative and post-operative uncorrected visual acuity, best corrected visual acuity, and refraction. Patient's corneal topographic profile. Corneal endothelial cell count on graft. Rates of graft rejection.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026