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.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Age ≥18 years but ≤50 years
History of keratoconus (without a previous transplant) requiring keratoplasty
Age < 18 years >50
Inability to provide written informed consent and comply with study assessments for the full duration of the study
Participation in another simultaneous interventional medical investigation or trial
History of Stevens-Johnson syndrome or ocular pemphigoid
Parallel
Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light
DrugA 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
DrugThe 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.
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery
• Best spectacle corrected visual acuity (BSCVA) with ETDRS methodology at 2.5 years (130 weeks) post-surgery
• Best spectacle corrected visual acuity (BSCVA) with ETDRS methodology at 2.5 years (130 weeks) post-surgery
Manifest cylinder astigmatism at 130 weeks post-surgery
Manifest cylinder astigmatism at 130 weeks post-surgerykeratometry, anterior mean keratometry, posterior mean keratometry
Uncorrected visual acuity (UCVA) 130 weeks post-surgery
Uncorrected visual acuity (UCVA) 130 weeks post-surgery
Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgery
Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgerypermeable contact lens.
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Joseph B. Ciolino, MD
Lead sponsor
Massachusetts Eye and Ear Infirmary
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
