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

Rheumatoid Arthritis Clinical Trial

Official title:

The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582880
• Other study ID #: 10-03-020
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2019
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chemical Injuries
• Lupus Erythematosus, Systemic
• Ocular Cicatricial Pemphigoid
• Other Autoimmune Diseases
• Pemphigoid, Bullous
• Rheumatoid Arthritis
• Stevens Johnson Syndrome
• Stevens-Johnson Syndrome
• Unspecified Complication of Corneal Transplant

Intervention

Drug:
• Riboflavin
Used to treat donor cornea before implantation

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joseph B. Ciolino, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	measured at week 4, 6, 26, 32, 52
Primary	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.	measured at week 4, 6, 26, 32, 52
Secondary	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.	post op week 52
Secondary	Ocular Safety	Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)	measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Secondary	Systemic Safety	Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).	measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52