{"id":"epithelium-off-riboflavin","safety":{"commonSideEffects":[{"rate":null,"effect":"Corneal haze"},{"rate":null,"effect":"Temporary vision reduction"},{"rate":null,"effect":"Epithelial defect healing delay"},{"rate":null,"effect":"Dry eye"}]},"_chembl":{"chemblId":"CHEMBL1534","moleculeType":"Small molecule","molecularWeight":"376.37"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a corneal cross-linking procedure used to halt or slow the progression of keratoconus and corneal ectasia. Riboflavin (vitamin B2) is applied topically to the cornea after removal of the epithelium, then activated by UVA light, generating free radicals that form covalent bonds between collagen molecules. This increases corneal biomechanical stability and halts disease progression.","oneSentence":"Epithelium-off riboflavin uses ultraviolet A light activation of riboflavin to create reactive oxygen species that cross-link corneal collagen, strengthening the cornea.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:13.644Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Keratoconus (progressive)"},{"name":"Post-refractive surgery corneal ectasia"},{"name":"Corneal weakening/ectasia"}]},"trialDetails":[{"nctId":"NCT07173907","phase":"","title":"Epi-on CuRV and Epi-off aCXL Protocols in the Management of Keratoconus","status":"COMPLETED","sponsor":"Gemini Eye Clinic","startDate":"2016-01-01","conditions":"Keratoconus","enrollment":135},{"nctId":"NCT05693740","phase":"NA","title":"Accelerated Corneal Collagen Crosslinking Protocols","status":"COMPLETED","sponsor":"Assiut University","startDate":"2022-08-01","conditions":"Keratoconus","enrollment":45},{"nctId":"NCT06549387","phase":"NA","title":"Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management","status":"NOT_YET_RECRUITING","sponsor":"Kasr El Aini Hospital","startDate":"2024-08-15","conditions":"Amount of Corneal Flattening (Kmax Flattening), Change in the Endothelial Cell Count","enrollment":55},{"nctId":"NCT03990506","phase":"NA","title":"Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus","status":"COMPLETED","sponsor":"Umeå University","startDate":"2019-04-02","conditions":"Keratoconus, Corneal Crosslinking, Corneal Biomechanics","enrollment":32},{"nctId":"NCT05691335","phase":"NA","title":"Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus","status":"COMPLETED","sponsor":"Sohag University","startDate":"2018-06-01","conditions":"Corneal Ectasia","enrollment":97},{"nctId":"NCT04383431","phase":"NA","title":"Cross-linking as Treatment in Infectious Keratitis","status":"COMPLETED","sponsor":"Sohag University","startDate":"2020-06-02","conditions":"Infectious Keratitis","enrollment":37},{"nctId":"NCT01708538","phase":"PHASE3","title":"The Effects of Corneal Collagen Cross-linking","status":"UNKNOWN","sponsor":"Rush Eye Associates","startDate":"2012-10","conditions":"Corneal Ectasia Disorders Including Keratoconus","enrollment":30},{"nctId":"NCT04045626","phase":"NA","title":"Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns","status":"UNKNOWN","sponsor":"Kasr El Aini Hospital","startDate":"2019-08-01","conditions":"Progressive Keratoconus","enrollment":20},{"nctId":"NCT03879421","phase":"NA","title":"Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.","status":"UNKNOWN","sponsor":"Reham Mahmoud Abdelrahman","startDate":"2016-10-01","conditions":"Keratoconus","enrollment":44},{"nctId":"NCT03858036","phase":"PHASE3","title":"Corneal Collagen Cross-Linking (CXL) Performed With \"Epi-ON\" Versus \"Epi-OFF\" in Eyes With Keratoconus and Other Corneal Ectatic Disorders","status":"UNKNOWN","sponsor":"Center for Sight, Sacramento, CA","startDate":"2019-03-08","conditions":"Keratoconus, Ectasia","enrollment":550},{"nctId":"NCT03753009","phase":"","title":"Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.","status":"COMPLETED","sponsor":"Bambino Gesù Hospital and Research Institute","startDate":"2013-01-01","conditions":"Keratoconus","enrollment":28},{"nctId":"NCT03080077","phase":"PHASE3","title":"Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia","status":"UNKNOWN","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2016-06","conditions":"Keratoconus, Ectasia","enrollment":8},{"nctId":"NCT02865876","phase":"PHASE3","title":"Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis","status":"UNKNOWN","sponsor":"Instituto de Oftalmología Fundación Conde de Valenciana","startDate":"2015-06","conditions":"Keratitis","enrollment":264},{"nctId":"NCT02867176","phase":"PHASE4","title":"Pain Management in Corneal Collagen Crosslinking for Keratoconus","status":"COMPLETED","sponsor":"Instituto de Oftalmología Fundación Conde de Valenciana","startDate":"2016-01","conditions":"Pain","enrollment":25},{"nctId":"NCT02762253","phase":"PHASE2","title":"Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.","status":"TERMINATED","sponsor":"Nvision Laser Eye Centers","startDate":"2012-09","conditions":"Keratoconus","enrollment":320},{"nctId":"NCT02638376","phase":"PHASE3","title":"Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus","status":"UNKNOWN","sponsor":"Singapore Eye Research Institute","startDate":"2013-03","conditions":"Keratoconus, Post LASIK Keratectasia","enrollment":66},{"nctId":"NCT02456961","phase":"NA","title":"Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin","status":"COMPLETED","sponsor":"Ufa Eye Research Institute","startDate":"2010-01","conditions":"Keratoconus","enrollment":126},{"nctId":"NCT02349165","phase":"NA","title":"Standard Versus Transepithelial Corneal Crosslinking","status":"COMPLETED","sponsor":"Nienke Soeters","startDate":"2011-05","conditions":"Keratoconus","enrollment":61},{"nctId":"NCT02095730","phase":"PHASE3","title":"Corneal Cross-Linking Comparing Variables","status":"UNKNOWN","sponsor":"Crowd Health Research, LTD","startDate":"2014-05","conditions":"Unstable Corneas","enrollment":500}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Vitamin B2"],"phase":"phase_3","status":"active","brandName":"Epithelium-Off Riboflavin","genericName":"Epithelium-Off Riboflavin","companyName":"Crowd Health Research, LTD","companyId":"crowd-health-research-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Epithelium-off riboflavin uses ultraviolet A light activation of riboflavin to create reactive oxygen species that cross-link corneal collagen, strengthening the cornea. Used for Keratoconus (progressive), Post-refractive surgery corneal ectasia, Corneal weakening/ectasia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}