PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

Condition(s) studied

Investigational drug(s) / intervention(s)

Schwind AMARIS excimer laser: Used for corneal wavefront guided PRK therapeutic ablation (50 µm) or for PTK epithelial removal, according to arm assignment.

Corneal collagen crosslinking epi-off accelerated: Riboflavin-UVA crosslinking performed after epithelial removal (corneal wavefront guided PRK arm via PRK; comparator arm via PTK). Intensity: 30 mW/cm² (pulsed 1 s on / 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J/cm². Total time (elapsed): 6 minutes \[equivalent to 3 minutes "on" time\].

Study summary

Keratoconus causes irregular astigmatism and reduced vision. Epi-off corneal crosslinking (CXL) stabilizes the cornea but often leaves higher-order aberrations uncorrected. This randomized, parallel-group trial compares corneal wavefront guided photorefractive keratectomy (corneal wavefront guided PRK, 50 µm therapeutic ablation) combined with accelerated epi-off CXL versus epi-off CXL with epithelial removal by phototherapeutic keratectomy (PTK) using a Schwind AMARIS excimer laser, in adults with keratoconus. The primary endpoint is change in best-corrected distance visual acuity (logMAR) at 12 months. Key secondary endpoints include Kmax, corneal higher-order aberrations, manifest refraction, Scheimpflug densitometry (haze) and Fantes grade, Corvis ST biomechanics, NEI VFQ-25, and endothelial cell density by non-contact specular microscopy at 1, 3, 6 and 12 months.

Eligibility

Primary outcome measure(s)

• Change in best-corrected distance visual acuity (logMAR) — Baseline to 12 months
  ETDRS-based CDVA in logMAR; change from baseline at 12 months; primary analysis by ANCOVA adjusted for baseline; one study eye per participant.

Trial sites (1)

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