--- title: Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas nct_id: NCT01189864 overall_status: TERMINATED sponsor: Cxlusa study_type: OBSERVATIONAL primary_condition: Keratoconus countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01189864.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01189864" ct_last_update_post_date: 2018-10-12 last_seen_at: "2026-05-12T07:23:21.586Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas **Official Title:** Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas **NCT ID:** [NCT01189864](https://clinicaltrials.gov/study/NCT01189864) ## Key Facts - **Status:** TERMINATED - **Why Stopped:** Terminated to initiate FDA IND-cleared study protocol - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 3493 - **Lead Sponsor:** Cxlusa - **Conditions:** Keratoconus, Ectasia, Degeneration - **Start Date:** 2010-02-01 - **Completion Date:** 2017-02-03 - **CT.gov Last Update:** 2018-10-12 ## Brief Summary The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops. ## Eligibility - **Minimum age:** 12 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 12 years of age or older * Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD). * Diagnosis of FFKC * History of Radial Keratotomy with fluctuating vision * Ability to provide written informed consent * Likely to complete all study visits * Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam * At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK) Exclusion Criteria: * Severe corneal scarring that markedly affects vision * Contraindications to any study medications or their components * Pregnancy or breast feeding * Active Herpes Corneal Disease ``` ## Arms - **Ciprofloxicin or Vigamox or other.** - **Nonsteroidal (Acular, Voltaren Xibrom, etc)** - **Steroid (FML, Pred Forte, Flarex, etc.)** ## Interventions - **Ciprofloxicin or Vigamox or other.** (DRUG) — Ciprofloxicin or Vigamox or other to be used qid till epithelialized. - **Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)** (DRUG) — Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op - **Steroid (FML, Pred Forte, Flarex, etc.)** (DRUG) — Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks. ## Primary Outcomes - **Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within** _(time frame: 1 year)_ ## Secondary Outcomes - **increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin** _(time frame: 1 year)_ ## Locations (16) - Schwartz Laser Eye Center, Scottsdale, Arizona, United States - Harvard Eye Associates, Laguna Hills, California, United States - Clear View Eye & Laser Medical Center, San Diego, California, United States - San Francisco, California, United States - Davidorf Eye Group, West Hills, California, United States - Corneal Consultants of Colorado, P.C, Littleton, Colorado, United States - The Center for Excellence in Eye Care, Miami, Florida, United States - Chicago Cornea Consultants, LTD, Hoffman Estates, Illinois, United States - TLC Laser Eye Center, Rockville, Maryland, United States - Talamo Laser Eye Center, Waltham, Massachusetts, United States - Ophthalomology Associates, St Louis, Missouri, United States - South Shore Eye Care LLP, Wantagh, New York, United States - Cleveland Eye Clinic, Brecksville, Ohio, United States - TLC Laser Eye Center, Fairfax, Virginia, United States - Northwest Eye Surgeons, Seattle, Washington, United States - Empire Eye Physicians, Spokane Valley, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.whyStopped` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.schwartz laser eye center|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.harvard eye associates|laguna hills|california|united states` — added _(2026-05-12)_ - `locations.clear view eye & laser medical center|san diego|california|united states` — added _(2026-05-12)_ - `locations.|san francisco|california|united states` — added _(2026-05-12)_ - `locations.davidorf eye group|west hills|california|united states` — added _(2026-05-12)_ - `locations.corneal consultants of colorado, p.c|littleton|colorado|united states` — added _(2026-05-12)_ - `locations.the center for excellence in eye care|miami|florida|united states` — added _(2026-05-12)_ - `locations.chicago cornea consultants, ltd|hoffman estates|illinois|united states` — added _(2026-05-12)_ - `locations.tlc laser eye center|rockville|maryland|united states` — added _(2026-05-12)_ - `locations.talamo laser eye center|waltham|massachusetts|united states` — added _(2026-05-12)_ - `locations.ophthalomology associates|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.south shore eye care llp|wantagh|new york|united states` — added _(2026-05-12)_ - `locations.cleveland eye clinic|brecksville|ohio|united states` — added _(2026-05-12)_ - `locations.tlc laser eye center|fairfax|virginia|united states` — added _(2026-05-12)_ - `locations.northwest eye surgeons|seattle|washington|united states` — added _(2026-05-12)_ - `locations.empire eye physicians|spokane valley|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01189864.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01189864* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*