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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.
Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen-MPC cornea substitute | Experimental | Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen-MPC cornea | Device | Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Healed Cornea at 12 Months | Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface | 12 months |
| Number of Participants With Improved Visual Acuity at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nataliya Pasyechnikova, MD, PhD, DSc | The Filatov Institute of Eye Diseases and Tissue Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Filatov Institute of Eye Diseases and Tissue Therapy | Odesa | 65061 | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19097643 | Result | Liu W, Deng C, McLaughlin CR, Fagerholm P, Lagali NS, Heyne B, Scaiano JC, Watsky MA, Kato Y, Munger R, Shinozaki N, Li F, Griffith M. Collagen-phosphorylcholine interpenetrating network hydrogels as corneal substitutes. Biomaterials. 2009 Mar;30(8):1551-9. doi: 10.1016/j.biomaterials.2008.11.022. Epub 2008 Dec 20. | |
| 20847116 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | RHCIII-MPC Cornea Substitute | Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RHCIII-MPC Cornea Substitute | Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events | Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom. | Posted | Number | events | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RHCIII-MPC Cornea Substitute | Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oleksiy Buznyk | Filatov Institite of Eye Diseases and Tissue Therapy of the NAMS of Ukraine | +380487181548 | a_buznik@bk.ru |
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| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| D003318 | Corneal Opacity |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity |
| 12 months |
| Hackett JM, Lagali N, Merrett K, Edelhauser H, Sun Y, Gan L, Griffith M, Fagerholm P. Biosynthetic corneal implants for replacement of pathologic corneal tissue: performance in a controlled rabbit alkali burn model. Invest Ophthalmol Vis Sci. 2011 Feb 3;52(2):651-7. doi: 10.1167/iovs.10-5224. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants With Healed Cornea at 12 Months | Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Improved Visual Acuity at 12 Months | Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 5 |
| 0 |
| 5 |
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| D005128 |
| Eye Diseases |