Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025
Visual rehabilitation in keratoconus by altering corneal shape using the corneal crosslinking pen: initial results.
Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA Phase I/II trial to evaluate the initial safety and performance of a novel corneal crosslinking device, the Corneal Crosslinking Pen in keratoconus patients. This was a prospective exploratory study with 12 months of follow up.
methodsTwenty-one eyes of 21 patients aged 14-27 years and diagnosed with progressive keratoconus were enrolled and treated unilaterally. Corneal crosslinking (CXL) following an accelerated epi-off protocol with riboflavin was done using the Corneal Crosslinking Pen. Effectiveness endpoints included changes in astigmatism, maximum keratometry (KMax), and best corrected visual acuity (BCVA) compared to baseline. Safety included adverse events and changes in pachymetry, intraocular pressure (IOP), and endothelial cell count (ECC).
resultsAstigmatism was significantly reduced at 12 months by a mean (95% CI) of 0.56 (0.10, 1.03) D. KMax was also reduced by a mean of 0.63 D, but this was not significant. BCVA improved significantly by nearly four lines of vision (- 0.38; logMAR). No corneal thinning was observed; pachymetry, IOP and ECC all remained stable across 12 months. Adverse events were infrequent and mild.
conclusionThese early results suggest that the Corneal Crosslinking Pen was safe and effective for CXL. Future studies will seek to confirm the large improvement seen for BCVA and elucidate a potential mechanism.
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