Abstract
Purpose :
The epithelial-off Dresden protocol is the only FDA-approved crosslinking (CXL) technique in the United States to treat keratoconus (KCN) progression. Previous clinical trials have demonstrated Peschke PXL-330, epithelial-on, accelerated CXL work is comparable to the Dresden protocol. However, it has not been established if a pulsed or continuous technique is superior in stabilizing the progression of KCN. This study assesses outcomes of epithelial-on CXL comparing a pulsed versus continuous protocol.
Methods :
Patients were treated with respect to the Declaration of Helsinki. IRB approval and informed consent were obtained. Those who met inclusion/exclusion criteria during screening were enrolled in this Phase 1/2 clinical trial. Patients were anesthetized with topical proparacaine, and riboflavin was administered via a scleral contact lens reservoir for 40 minutes, followed by CXL with Peschke PXL-330. Patients were randomized into one of the following groups: pulsed (18 mW/cm2 fluence with 5 seconds on 5 seconds off for 10 minutes) or continuous (9 mW/cm2 fluence continuously for 10 minutes). A subset of patients elected to undergo concurrent placement of intracorneal ring segment(s). Patients were followed for 1 year (at 1 day, 2 weeks, 3, 7, and 12 months). Maximum keratometry (Kmax), central corneal thickness, best corrected visual acuity (BCVA) (ETDRS), intraocular pressure, and vision questionnaires were assessed throughout the post operative appointments.
Results :
Thirty-three patients (44 total eyes) have completed all postoperative visits, with 17 eyes receiving pulsed protocol treatment and 27 eyes receiving the continuous protocol. Kmax decreased in the continuous group by 2.59 diopters and 3.47 in the pulsed group. BCVA score increased by 4.30 in the continuous group and 3.47 in the pulsed group. There was no significant difference in Kmax (p=0.22) and BCVA (p=0.42) between the two groups. No adverse events were observed.
Conclusions :
The Peschke PXL-330 device shows promising results for treating KCN and other corneal thinning conditions. Epithelium-on CXL technique reduces patient risk of infections, scarring, and pain following treatment. Both continuous and pulsed epithelium-on groups can be used to slow the progression of these corneal diagnoses with no significant difference between the two protocols.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.