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

Phase 1

Completed

• Conditions: Chemical Injuries; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Other Autoimmune Diseases; Unspecified Complication of Corneal Transplant; Lupus Erythematosus, Systemic; Rheumatoid Arthritis
• Interventions: Drug: Riboflavin

• Registration Number: NCT01582880
• Lead Sponsor: Joseph B. Ciolino, MD

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2017-03-21
• Results First Submitted QC: 2017-06-28
• Results First Posted: 2017-07-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Riboflavin Cross-linked donor cornea	Riboflavin	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.

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Thickness at 1 Millimeter	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	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

Name	Time	Method
Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers	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	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	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).

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States