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

Primary Purpose

Leukoma

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

RHCIII-MPC cornea

Donor cornea

About this trial

This is an interventional treatment trial for Leukoma focused on measuring keratoplasty, bioengineered cornea, donor cornea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

L V Prasad Eye Institute, Centre for Ocular Regeneration

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RHCIII-MPC cornea

Donor cornea

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The implant/donor cornea graft biocompatability will be checked by degree of haze and/or vascularisation measured on a scale 0-4 (0 - transparent implant/graft, no vessels, 4 - haze does not allow visualizing pupil, vessels enter entire surface of implant/graft)

Visual acuity measured by LogMAR

Full Information

NCT ID

NCT02424006

First Posted

April 10, 2015

Last Updated

August 7, 2018

Sponsor

L.V. Prasad Eye Institute

Collaborators

Linkoeping University

1. Study Identification

Unique Protocol Identification Number

NCT02424006

Brief Title

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

Official Title

A Prospective, Randomized, Open Label Clinical Trial to Evaluate the Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea Compared to Human Cornea in Patients Requiring Anterior Lamellar Keratoplasty

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

May 2015 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

L.V. Prasad Eye Institute

Collaborators

Linkoeping University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukoma

Keywords

keratoplasty, bioengineered cornea, donor cornea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

RHCIII-MPC Biosynthetic Cornea

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RHCIII-MPC cornea

Arm Type

Experimental

Arm Description

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

Arm Title

Donor cornea

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

RHCIII-MPC cornea

Intervention Description

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

Intervention Name(s)

Donor cornea

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety (Degree of eye inflammation)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Title

Visual acuity measured by LogMAR

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virender S Sangwan, MBBS, MS

Organizational Affiliation

LV Prasad Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

L V Prasad Eye Institute, Centre for Ocular Regeneration

City

Hyderabad

ZIP/Postal Code

500034

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

19097643

Citation

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.

Results Reference

result

PubMed Identifier

24374070

Citation

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.

Results Reference

result

Learn more about this trial

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

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