Evaluation of Biosynthetic Constructs to Replace Donor Corneas

Evaluation of Biosynthetic Constructs as Replacement for Donor Corneas as Graft Material for Corneal Transplantation

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.

Study Overview

• Status: Withdrawn
• Conditions: Corneal Disease
• Intervention / Treatment: Device: NuCornea; Device: donated human corneas

Detailed Description

12 patients will be recruited from the waitinglist for corneal transplantation.The will all be of the age of 18 years or older and capable of making their own decisions. Their medical history and present medication is reveiwed and they undergo a thorough ophthalmological examination in order to find out if they meet the inclusion criteria and create baseline values for the study. Their general health or medication should not affect the cornea or ocular surface. The Eye should be healthy with the exception of the disease indication for corneal grafting. The corneal endothelium should be healthy. Any opacification in the eye to be grafted should not reach the Descemets membrane. Visual acuity in the fellow eye should be good. If these criteria are met the patient recieve oral and written information of the study. If they agree to participate they will be randomized to either recieve biosynthetic corneas ( 6 patients) or they will recieve a donated cornea ( 6 patients) . They will be scheduled for surgery within 2 weeks from the examination irrespective if they participate in the study or not.

The surgery will be anterior deep lamellar using the femtosecond laser to do the patient cut. The laser cut wil be done in topical anaaestesi. The remaining surgery with either be performed in local oor general anaestesia according to the patients wish. The diameter of the cut will be 7 mm in diameter. The graft material will be punched to a diameter of 7.25 mm. The thickness of the material will be 500 µm . An amniotic membrane will be placed on the top of the biosynthetic material and sutured with single stiches together with the graft.A bandage lens will be placed . The donated corneas will be sutured with singled about 8 stiches.

The biosynthetic corneas will recieve topical antibiotics and dexametasone for 8 weeks when the sutures, remnants of the amniotic membrane and the bandage lens is removed. The donated corneas will recieve topical dexametasone for 5 months and the sutures will be removed after 6 months.

The check-up Schedule will be at 1 day,1,2 weeks,1,,2 months and extra when needed.The protocol in these check-ups will be descriptive and the exyes will be documented with slit lamp photography. Epitelialisation will be monitored with fluorescein staining.

At the 3,6,9 and12 months will be extensive and the same in both groups. UCVA and BSCVA will be measured and also BCLCVA at 12 months. Corrneal topography,thickness sensitivity,tear production Visante OCT and slit- lamp photography will be performed. Tear samples will be taken also form earlier check-ups for proteomic analysis. In vivo confocal microscopy will be performed. The different examination with few exceptions can all be presented in results that can be quantified and statistically analysed.

The CRFs and the adverse report forms will be filled out both on computer forms and on paper.

The safety outcome criteria are: Good engraftment, maintained integrity of the graft, epithelialisation, transparency,no induced inflammation,no induced vasculatisation.

The preliminary efficacy criteria are: UCVA,BSCVA and BCLCVA

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NuCornea (Biosynthetic corneas); 6 patients will receive biosynthetic corneas when undergoing corneal transplantation	Device: NuCornea; Deep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea; Other Names: Biosynthetic cornea
ACTIVE_COMPARATOR: Donated human corneas; 6 patients will receive a donated human cornea when undergoing corneal transplantation	Device: donated human corneas; Deep anterior lamellar corneal transplantation with a donated cornea as graft material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Best spectacle corrected visual acuity,Best contactlens corrected Visual acuity	1 year

Collaborators and Investigators

• Sponsor: Region Östergötland
• Collaborators: The Swedish Research Council
• Investigators: Principal Investigator: Per Fagerholm, MD,PhD, Dept of Ophthalmology, University Hospital, Linköping,Sweden

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (ESTIMATE): March 2, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: vision; improve
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases
• Other Study ID Numbers: DNr52120125706