A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Joseph B. Ciolino, MD
Study ID
NCT04584125
Status
Not Yet Recruiting

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Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light — DRUG
    A wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J/cm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 2 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea.
  • Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light — DRUG
    The corneal tissue for the control arm will be treated the same as the crosslinked tissue except that it will not be exposed to ultraviolet light. The donor cornea will be placed on an artificial anterior chamber maintainer and the epithelium will be removed mechanically. Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes.

Study Details

This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.

Key Dates

Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
May 1, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ex vivo cross linking of donor corneal tissue
    Treatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking.
  • Sham Comparator: Non-cross-linked donor corneal tissue for keratoplasty
    Control Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking.

Primary Outcome Measure

• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery. [ Time Frame: 130 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114
Joseph Ciolino, MD
[email protected]
617-573-5575

Find similar trials in Boston, MA

By research site
Massachusetts Eye and Ear Infirmary· Boston, MA

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