Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty

NCT ID: NCT02424006

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-12-31

Brief Summary

In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.

Detailed Description

Recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. Control patients with same condition will be grafted with human donor cornea using the same surgical technique.

The investigators will test the safety and the effectiveness of developed biosynthetic corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups - 10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with human donor cornea. The patients will be follow-uped for 12 months.

Conditions

Leukoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RHCIII-MPC cornea

Patients of this arm will undergo RHCIII-MPC bioengineered cornea transplantation using anterior lamellar keratoplasty technique

Group Type: EXPERIMENTAL

RHCIII-MPC cornea

Intervention Type: DEVICE

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A RHCIII-MPC cornea 350 um 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.

Donor cornea

Patients of this arm will undergo human donor cornea transplantation using anterior lamellar keratoplasty technique

Group Type: ACTIVE_COMPARATOR

Donor cornea

Intervention Type: DEVICE

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A human donor cornea graft 350 um thick and 0.25 mm larger diameter is placed and sutured. The sutures will be removed in 3-6 months or as determined by physician.

Interventions

RHCIII-MPC cornea

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A RHCIII-MPC cornea 350 um 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.

Intervention Type: DEVICE

Donor cornea

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A human donor cornea graft 350 um thick and 0.25 mm larger diameter is placed and sutured. The sutures will be removed in 3-6 months or as determined by physician.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must sign and be given a copy of the written Informed Consent form.
• Subjects with best corrected distance visual acuity +1.0 LogMAR or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye.
• Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria

• Subjects with severe or life-threatening systemic disease.
• Subjects with uncontrolled hypertension.
• Subjects with uncontrolled diabetes or insulin-dependent diabetes.
• Subjects with glaucoma in either eye.
• Subjects with marked microphthalmos or aniridia in either eye.
• Subjects with any other serious ocular pathology, serious ocular complications at the time of surgery underlying serious medical conditions, based on the investigator's medical judgment.
• Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

L.V. Prasad Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Virender S Sangwan, MBBS, MS

Director, Center for Ocular Regeneration

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virender S Sangwan, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

LV Prasad Eye Institute

Locations

L V Prasad Eye Institute, Centre for Ocular Regeneration

Hyderabad, , India

Countries

India

References

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.

Reference Type: RESULT

PMID: 19097643 (View on PubMed)

Fagerholm P, Lagali NS, Ong JA, Merrett K, Jackson WB, Polarek JW, Suuronen EJ, Liu Y, Brunette I, Griffith M. Stable corneal regeneration four years after implantation of a cell-free recombinant human collagen scaffold. Biomaterials. 2014 Mar;35(8):2420-7. doi: 10.1016/j.biomaterials.2013.11.079. Epub 2013 Dec 25.

Reference Type: RESULT

PMID: 24374070 (View on PubMed)

Other Identifiers

LVPEI-RHCIII-MPC CORNEA

Identifier Type: OTHER

Identifier Source: secondary_id

201503-001

Identifier Type: -

Identifier Source: org_study_id