Evaluation of Biosynthetic Constructs to Replace Donor Corneas

NCT02374723 | Withdrawn Phase 1 DMC

• 1 other identifier: DNr52120125706
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. The twelve patients will be recruited from the local waiting list for patients to be undergoing corneal grafting. If the patients meet the inclusion criteria and agree to participate following oral and written consent, they will be randomized to either group. The patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy, slit lamp photography a o. The study is planned as a safety study with initial efficacy documentation.

Conditions

Corneal Disease

Keywords

improve; vision

Outcome Measures

Primary Outcomes (1)

• Biocompatibility: Good engraftment,epithelialization, no neovascularization,retained transparency, no host inflammatory reaction

  Device replacing human donor cornea at Deep anterior lamellar transplantation.

  1 year

Secondary Outcomes (1)

• Visual acuity

  1 year

Study Arms (2)

NuCornea (Biosynthetic corneas)

EXPERIMENTAL

6 patients will receive biosynthetic corneas when undergoing corneal transplantation

Device: NuCornea

Donated human corneas

ACTIVE COMPARATOR

6 patients will receive a donated human cornea when undergoing corneal transplantation

Device: donated human corneas

Interventions

NuCornea DEVICE

Deep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea

Also known as: Biosynthetic cornea

NuCornea (Biosynthetic corneas)

donated human corneas DEVICE

Deep anterior lamellar corneal transplantation with a donated cornea as graft material.

Donated human corneas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for Deep anterior lamellar corneal transplantation.
• No topical Eye medication.

You may not qualify if:

• No Eye disease other than the indication for the corneal graft.
• No general disease that might affect the cornea.
• No general medication that might affect the cornea.

Sponsors & Collaborators

• Region Östergötland: lead
• The Swedish Research Council: collaborator

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Per Fagerholm, MD,PhD

  Dept of Ophthalmology, University Hospital, Linköping,Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor,MD,PhD

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 2, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 15, 2016

Record last verified: 2016-04