A recent study conducted by Steven Greenstein evaluated the long-term effects of Epi-off corneal collagen cross-linking (CXL) treatment.
This therapy was first FDA approved in 2016. It is a therapy for progressive keratoconus, as well as ectasia, which can occur after refractive surgery. This study thankfully found that the treatment is stable for most patients in the 10 years post-surgery.
This study was a single-center investigation, but it was part of the larger Phase 3 trial for CXL in these conditions. Its primary outcome was changes in Kmax. Other outcomes investigated were logMAR, UCVA, and BCVA.
There were a total of 16 patients in this study, and a total of 30 eyes were studied. Of the eyes, 15 had ectasia and 15 had keratoconus. All had experienced laser refractive surgery.
Here are some of the most notable results
- Treated keratoconus patients had an 86.7% stable topography at the 10-year mark
- 26.7% of treated keratoconus patients had 2 diopters improve or increased flattening of their cornea
- 60% of keratoconus eyes did not have changes in visual acuity
- 20% of keratoconus eyes had a gain of 2 or more lines of logMAR UCVA
- 60% of keratoconus eyeshadow had stable BCVA and 40% had 2 line improvement or better
- Treated ectasia patients had a 66.7% stable topography at the 10-year mark
- 53.3% of treated ectasia patients had 2 diopters improve or increased flattening of their cornea
- Among ectasia treated eyes, 21.4% were stable during the 10 years
- Among ectasia treated eyes, 21.4% had an increase of 2 or more lines of UCVA logMAR vision
- Among ectasia treated eyes, BCVA was stable during the 10 years for 50%
- Among ectasia treated eyes, 21.4% had an increase of 2 or more lines in VA
- Among keratoconus patients, 60% were stable on topography analyses
- Among keratoconus patients, 26.7% had a 2-diopter or an increased flattening of their cornea
- Among ectasia patients, 13.3% were stable on topography analyses
- Among ectasia patients, 53.5% had a 2-diopter or increased flattening of the cornea
- 93.3% of all keratoconus patients, as well as 64.3% of ectasia patients, didn’t experience any progression in the corneal curvature (either anterior or posterior).
The researchers concluded that overall, CXL seems to be stable after 10 years. This is incredible news for this patient population. Overall, topography was found to be stable in 77% of all eyes in the study, 87% of all of the keratoconic eyes, as well as in 67% of the ectasia eyes. Further, BCVA was found to be stable in 88% of all eyes, 100% of keratoconic eyes, as well as 71.4% of ectasia eyes.
You can read the full study here.