CompletedPhase 1/2

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

United States1 participantsStarted 2012-03

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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:

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

What they're measuring

Changes in Corneal Thickness at 1 Millimeter

Timeframe: measured at week 4, 6, 26, 32, 52

Changes in Corneal Thickness at 2 Millimeter

Timeframe: measured at week 4, 6, 26, 32, 52

Trial details

NCT IDNCT01582880

SponsorJoseph B. Ciolino, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2017-03-21

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