Early Clinical Trial Data Shows Potential of Corneal Allograft Inlay in Patients With Presbyopia
Implanting a sterile allograft corneal inlay in the non-dominant eye of patients with presbyopia has the potential to improve near vision, according to early results of an ongoing clinical trial. The corneal allograft has a refractive add power of +2.5 D and is designed to improve near vision by increasing depth of focus and corneal power.
Data from the first 10 patients (mean age: 52 years [range: 46 to 57 years]) enrolled in the prospective trial were presented by Aylin Kiliç, MD, associate professor of Ophthalmology, Medipol University, Istanbul, Turkey, at the 2019 ASCRS-ASOS annual meeting.
At 3-month follow-up, near uncorrected visual acuity (UCVA) better than 20/40 was achieved in all patients. Due to a slight myopic refractive shift, 70% of implanted eyes lost 1 line of distance UCVA; however, all patients maintained 20/20 binocular distance UCVA.
Mean near UCVA and mean distance corrected near visual acuity improved significantly compared to preoperative data. No significant changes in mean corneal thickness or best corrected distance visual acuity were found. There was a significant change in mean spherical equivalent from +0.06 D preoperatively to -0.47 D at 3-month follow-up.
Dr. Kiliç reported that larger clinical studies are now needed to demonstrate effectiveness with long-term follow-up.
Kiliç, A. A prospective multicenter clinical study to evaluate the safety and effectiveness of intrastromal implant of the transform corneal allograft (TCA) for providing near vision in presbyopic subjects. Presented at: ASCRS-ASOA annual meeting; May 3-7, 2019; San Diego, CA.