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

Primary Purpose

Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Riboflavin
Sponsored by
Joseph B. Ciolino, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemical Injuries focused on measuring Keratoprosthesis, sterile cornea ulcer

Eligibility Criteria

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

Inclusion Criteria:

  1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  2. Age > 18 years.
  3. A negative urine pregnancy test.
  4. Candidate for a Boston Keratoprosthesis/Corneal transplant.
  5. Generally good stable overall health.

  6. 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:

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

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Riboflavin Cross-linked donor cornea

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in Corneal Thickness at 1 Millimeter
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
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
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
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Systemic Safety
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).

Full Information

First Posted
April 10, 2012
Last Updated
October 18, 2019
Sponsor
Joseph B. Ciolino, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01582880
Brief Title
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
Official Title
The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph B. Ciolino, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases, Ocular Cicatricial Pemphigoid, Stevens Johnson Syndrome, Lupus Erythematosus, Systemic, Rheumatoid Arthritis, Other Autoimmune Diseases
Keywords
Keratoprosthesis, sterile cornea ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riboflavin Cross-linked donor cornea
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Other Intervention Name(s)
Riboflavin (vitamin B2) 0.1% solution
Intervention Description
Used to treat donor cornea before implantation
Primary Outcome Measure Information:
Title
Changes in Corneal Thickness at 1 Millimeter
Description
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.
Time Frame
measured at week 4, 6, 26, 32, 52
Title
Changes in Corneal Thickness at 2 Millimeter
Description
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.
Time Frame
measured at week 4, 6, 26, 32, 52
Secondary Outcome Measure Information:
Title
Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
Description
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.
Time Frame
post op week 52
Title
Ocular Safety
Description
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Time Frame
measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Title
Systemic Safety
Description
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Time Frame
measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ciolino, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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