Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis - Full Text View

Purpose

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

Condition	Intervention	Phase
Chemical Injuries Unspecified Complication of Corneal Transplant Autoimmune Diseases Ocular Cicatricial Pemphigoid Stevens Johnson Syndrome Lupus Erythematosus, Systemic Rheumatoid Arthritis Other Autoimmune Diseases	Drug: Riboflavin	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

Drug Information available for: Riboflavin

Genetic and Rare Diseases Information Center resources: Bullous Pemphigoid Stevens-Johnson Syndrome Cicatricial Pemphigoid Ocular Cicatricial Pemphigoid Erythema Multiforme

U.S. FDA Resources

Further study details as provided by Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

Changes in Corneal Thickness at 1 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Changes in Corneal Thickness at 2 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.

Secondary Outcome Measures:

Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers [ Time Frame: post op week 52 ]
Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.
Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Systemic Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).


Enrollment:	1
Study Start Date:	March 2012
Study Completion Date:	March 2017
Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Riboflavin Cross-linked donor cornea the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.	Drug: Riboflavin Used to treat donor cornea before implantation Other Name: Riboflavin (vitamin B2) 0.1% solution

Detailed Description:

The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years.
A negative urine pregnancy test.
Candidate for a Boston Keratoprosthesis/Corneal transplant.
Generally good stable overall health.
Patients with an eye at risk for a cornea sterile ulcer which includes:
- Chemical injuries.
- Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
- History of previous sterile corneal ulceration requiring a cornea transplant.

Exclusion Criteria:

Age < 18 years.
Inability to provide written informed consent and comply with study assessments for the full duration of the study.
Pregnant or lactating women.
No or minimal tear production.
Ocular or periocular malignancy.
Inability to wear a contact lens due to lid abnormalities or shortened fornix.
Signs of current infection, including fever and current treatment with antibiotics.
Participation in another simultaneous medical investigation or trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582880

Locations


United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Joseph B. Ciolino, MD

Investigators


Principal Investigator:	Joseph Ciolino, MD	Massachusetts Eye and Ear Infirmary

More Information


Responsible Party:	Joseph B. Ciolino, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT01582880 History of Changes
Other Study ID Numbers:	10-03-020
Study First Received:	April 10, 2012
Results First Received:	March 21, 2017
Last Updated:	June 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary:


Keratoprosthesis sterile cornea ulcer

Additional relevant MeSH terms:


Arthritis, Rheumatoid Autoimmune Diseases Lupus Erythematosus, Systemic Pemphigoid, Bullous Stevens-Johnson Syndrome Pemphigoid, Benign Mucous Membrane Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Immune System Diseases Skin Diseases, Vesiculobullous Skin Diseases Stomatitis	Mouth Diseases Stomatognathic Diseases Drug Eruptions Dermatitis Erythema Multiforme Erythema Drug Hypersensitivity Hypersensitivity Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Conjunctival Diseases Eye Diseases Riboflavin Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on August 18, 2017