International ophthalmology · 2026
Vitamin E TPGS-enhanced riboflavin accelerated transepithelial cross-linking versus accelerated epithelium-off protocol in progressive keratoconus: a prospective randomized trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jain Parul, Rangari Pushkar, Dutta Paromita, Pradhan Avinash
Аннотация
PURPOSE: To compare the efficacy and safety of accelerated transepithelial (epi-on) corneal collagen cross-linking (CXL) using a Vitamin E D-α-tocopheryl polyethylene glycol succinate (TPGS)-enhanced riboflavin formulation with an accelerated epithelium-off (epi-off) CXL protocol in progressive keratoconus.
DESIGN: Prospective randomized comparative clinical trial.
METHODS: Fifty eyes of fifty patients aged 12-35 years with documented progressive keratoconus were randomized (1:1). In the epi-on group, 0.1% riboflavin enhanced with Vitamin E TPGS was used followed by UVA irradiation at 9 mW/cm2 for 10 min (total fluence 5.4 J/cm2). In the epi-off group, the epithelium was removed, the cornea was saturated with iso-osmolar 0.1% riboflavin, and identical UVA irradiation was applied. The primary outcome was change in maximum keratometry (Kmax) at 12 months. Secondary outcomes included UDVA, CDVA, refractive error, keratometric indices, corneal pachymetry, higher-order aberrations, stromal demarcation line depth, endothelial cell density, and safety parameters (infectious keratitis, persistent epithelial defect, clinically significant haze, endothelial decompensation, and sustained IOP rise requiring therapy).
RESULTS: Both groups showed significant improvement in UDVA/CDVA and significant flattening of keratometric parameters at 12 months (all intragroup p < 0.001). Mean corneal thickness behavior differed between groups, with relative pachymetric preservation in the epi-on arm compared with thinning in the epi-off arm (intergroup p < 0.05). Demarcation line depth was deeper in the epi-off arm (p < 0.001). No sight-threatening complications, endothelial decompensation, or sustained IOP elevation were observed in either group.
CONCLUSIONS: At 12 months, accelerated transepithelial CXL using a Vitamin E TPGS-enhanced riboflavin formulation demonstrated visual and tomographic stabilization comparable to accelerated epi-off CXL.
CLINICAL TRIAL REGISTRATION: CTRI /2024/06/069279.
DESIGN: Prospective randomized comparative clinical trial.
METHODS: Fifty eyes of fifty patients aged 12-35 years with documented progressive keratoconus were randomized (1:1). In the epi-on group, 0.1% riboflavin enhanced with Vitamin E TPGS was used followed by UVA irradiation at 9 mW/cm2 for 10 min (total fluence 5.4 J/cm2). In the epi-off group, the epithelium was removed, the cornea was saturated with iso-osmolar 0.1% riboflavin, and identical UVA irradiation was applied. The primary outcome was change in maximum keratometry (Kmax) at 12 months. Secondary outcomes included UDVA, CDVA, refractive error, keratometric indices, corneal pachymetry, higher-order aberrations, stromal demarcation line depth, endothelial cell density, and safety parameters (infectious keratitis, persistent epithelial defect, clinically significant haze, endothelial decompensation, and sustained IOP rise requiring therapy).
RESULTS: Both groups showed significant improvement in UDVA/CDVA and significant flattening of keratometric parameters at 12 months (all intragroup p < 0.001). Mean corneal thickness behavior differed between groups, with relative pachymetric preservation in the epi-on arm compared with thinning in the epi-off arm (intergroup p < 0.05). Demarcation line depth was deeper in the epi-off arm (p < 0.001). No sight-threatening complications, endothelial decompensation, or sustained IOP elevation were observed in either group.
CONCLUSIONS: At 12 months, accelerated transepithelial CXL using a Vitamin E TPGS-enhanced riboflavin formulation demonstrated visual and tomographic stabilization comparable to accelerated epi-off CXL.
CLINICAL TRIAL REGISTRATION: CTRI /2024/06/069279.