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

NCT02424006 | Completed DMC

• 2 other identifiers: 201503-001LVPEI-RHCIII-MPC CORNEA
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukoma

Keywords

keratoplasty; bioengineered cornea; donor cornea

Outcome Measures

Primary Outcomes (1)

• Safety (Degree of eye inflammation)

  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

Secondary Outcomes (2)

• Biocompatability, degree of haze and/or vascularisation measured on a scale 0-4

  12 months

• Visual acuity measured by LogMAR

  12 months

Study Arms (2)

RHCIII-MPC cornea

EXPERIMENTAL

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

Device: RHCIII-MPC cornea

Donor cornea

ACTIVE COMPARATOR

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

Device: Donor cornea

Interventions

RHCIII-MPC cornea 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.

RHCIII-MPC cornea

Donor cornea 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.

Donor cornea

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead
• Linkoeping University: collaborator

Study Sites (1)

L V Prasad Eye Institute, Centre for Ocular Regeneration

Hyderabad, 500034, India

Location

Related Publications (2)

• 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.

  PMID: 19097643 RESULT

• 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.

  PMID: 24374070 RESULT

MeSH Terms

Conditions

Corneal Opacity

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Virender S Sangwan, MBBS, MS

  LV Prasad Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Ocular Regeneration

Model Details: RHCIII-MPC Biosynthetic Cornea

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 22, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2015-04

Locations

IN (1)