[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407338":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":67,"collaborators":43,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":43,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":95,"whyStopped":43,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ex vivo cross linking of donor corneal tissue","EXPERIMENTAL","Treatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking.",[13],"Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-cross-linked donor corneal tissue for keratoplasty","SHAM_COMPARATOR","Control Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking.",[19],"Drug: Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% with UV light","A wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J\u002Fcm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 2 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea.",[9],[27],"PHOTREXA VISCOUS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146% without UV light","The corneal tissue for the control arm will be treated the same as the crosslinked tissue except that it will not be exposed to ultraviolet light. The donor cornea will be placed on an artificial anterior chamber maintainer and the epithelium will be removed mechanically. Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes.",[15],[27],[34],{"name":35,"affiliation":36,"role":37},"Joseph B Ciolino","Massachusetts Eye and Ear","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Joseph B Ciolino, MD","CONTACT","(617) 573-3938",null,"Joseph_Ciolino@MEEI.HARVARD.EDU",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Ellen Fitzgerald","617-573-6971","Ellen_Fitzgerald@MEEI.HARVARD.EDU",[50],{"facility":5,"status":43,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Boston","Massachusetts","02114","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":43,"email":66},"Joseph Ciolino, MD","617-573-5575","Joseph_Ciolino@meei.harvard.edu",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Joseph B. Ciolino, MD","Associate Professor of Ophthalmology","100407338","a-randomized-clinical-trial-of-ex-vivo-corneal-cross-linking-of-donor-keratoplasty-tissue-for-keratoconus-used-for-keratoplasty-in-keratoconus-patients-100407338",false,"NCT04584125","A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients","A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus","EVOKE","Inclusion Criteria:\n\n* Willing and able to provide written informed consent.\n* Willing and able to comply with study assessments for the full duration of the study.\n* Age ≥18 years but ≤50 years\n* History of keratoconus (without a previous transplant) requiring keratoplasty\n* Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years \\>50\n* Inability to provide written informed consent and comply with study assessments for the full duration of the study\n* Participation in another simultaneous interventional medical investigation or trial\n\nSystemic\n\n* History of Stevens-Johnson syndrome or ocular pemphigoid\n* Signs of current infection, including fever and current treatment with antibiotics\n* Pregnancy (positive pregnancy test) or lactating\n* Pre-menopausal sexually active women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)\n\nRecipient Eye\n\n* Corneal or ocular surface infection within 30 days prior to study entry\n* History of previous cross-linking\n* History of previous corneal transplant\n* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively\n* Ocular or periocular malignancy\n* Lid abnormalities that in the opinion of the investigator could confound the study results and these include clinically significant ectropion, lagophthalmos, cicatrization, entropion, and rosacea\n* Neurotrophic cornea\n* Monocular\n* Uncontrolled glaucoma\n* Glaucoma filtering devices or trabeculectomies","ALL","18 Years","50 Years",{"count":83,"type":84},216,"ESTIMATED","INTERVENTIONAL",[87],"NA","This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.",[90],"Keratoconus",[92,93,94],"Corneal Crosslinking","Penetrating Keratoplasty","Deep Anterior Lamellar Keratoplasty","NOT_YET_RECRUITING","2026-04-02",{"date":98,"type":99},"2026-04-08","ACTUAL",{"date":101,"type":84},"2027-01-01",{"date":103,"type":84},"2028-11-30",{"name":69,"class":6},1]