- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02865876
Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis
Effectiveness of Corneal Accelerated Crosslinking Versus Conventional Treatment for Infectious Keratitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators perform a comprehensive ophthalmological examination, including evaluation of risk factors (immunosuppressive status, ocular trauma, previous ocular surgery, contact lens wear, topical corticosteroids use), best-corrected visual acuity (Snellen chart), slit-lamp biomicroscopy, tonometry and fundoscopy. In addition, anterior segment optical coherence tomography imaging (Visante, Carl Zeiss Meditec, Dublin, California, USA), corneal scrapes, culture and clinical photographs at day 1, day 7, month 1 and 3 will be analyzed.
Each participant will be assigned to one of four groups after randomization. Group 1: Initial ulcer on treatment with antibiotic plus sham (n = 66), these partcipants will receive only topical moxifloxacin 0,5% (Vigamoxi, Alcon, Texas, USA) and sham CXL; Group 2: Initial ulcer on treatment with antibiotic plus cross-linking (CXL) (n = 66) receive moxifloxacin plus CXL (riboflavin 0.1% during 10 minutes and irradiation 30 mW/cm2 during 3 minutes using accelerated CXL); Group 3: Refractory corneal ulcer on treatment with antibiotic plus sham (n=66), receive only topical antibiotic plus sham CXL; Group 4: Refractory corneal ulcer on treatment with antibiotic plus CXL will receive their standard medications plus CXL.
Statistical analysis will be divided into four phases: 1) Analysis of compliance, 2) Intention to treat, 3) Losses to follow-up and 4) Variable-response (healing) using Stata/MP 12.0 (Stata Corp., College Station, TX).
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Lucero Pedro-Aguilar, MD
- Phone Number: 3204 +5255880000
- Email: lu.pedroaguilar@gmail.com
Study Contact Backup
- Name: Aida Jimenez-Corona, PhD
- Phone Number: 3123 +5255880000
- Email: aidaajc@gmail.com
Study Locations
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-
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Mexico City, Mexico, 06800
- Recruiting
- INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA
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Contact:
- Lucero Pedro-aguilar, MD
- Email: lu.pedroaguilar@gmail.com
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Contact:
- Enrique Graue-Hernandez, MD, MSc
- Email: egraueh@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with infectious keratitis (initial or refractory to treatment) including bacterial or mycotic keratitis with size larger than 3 mm
Exclusion Criteria:
- herpetic keratitis
- Acanthamoeba keratitis
- pregnancy
- endophthalmitis
- systemic immunosuppression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Accelerated Corneal Cross-linking
Cross-linking in the management of microbial keratitis is an adjunctive therapy.This procedure is conducted under sterile conditions in the operating room.
Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia.
The corneal epithelium on the edge of the ulcer is cautiously removed using a microsponge.
As photosensitizer, riboflavin 0.1% (Vibex, Avedro Inc, Waltham, USA) is used for 10 minutes.
After impregnation, the participant´s cornea is irradiaded with UVA-light (370 nm) using 30 mW/cm2 for 3 minutes (which corresponds to a total dose of 5.4J/cm2) with accelerated cross-linking (Avedro Inc., Waltham, USA).
After procedure, conventional treatment for keratitis remains unchanged.
|
All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.
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SHAM_COMPARATOR: Sham Accelerated Corneal Cross-linking
Placebo surgery.
This procedure is conducted under sterile conditions in the operating room.
Tetracaine hydrochloride 0.5% (Ponti Ofteno, Sophia, Mexico) eye drops is apply for topical anesthesia.
Investigators do not perform removal of the corneal epithelium in edge of the ulcer.
The researchers conducted "the impregnation phase" applying drops of saline solution for 10 minutes.
After impregnation fase, a device is placed in Avedro equipment off (Avedro Inc, Waltham, USA) this device emits white light for 3 minutes.
After procedure, conventional treatment for keratitis remains unchanged.
|
All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing
Time Frame: Three months
|
Full epithelialization without evidence of infiltrates
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: Three months
|
Complications associated with accelerated corneal cross-linking, such as corneal perforation or progression
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Three months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Enrique Graue-Hernandez, MSc, Instituto de oftalmología Fundación Conde de Valenciana
Publications and helpful links
General Publications
- Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
- Li Z, Jhanji V, Tao X, Yu H, Chen W, Mu G. Riboflavin/ultravoilet light-mediated crosslinking for fungal keratitis. Br J Ophthalmol. 2013 May;97(5):669-71. doi: 10.1136/bjophthalmol-2012-302518. Epub 2013 Jan 26. No abstract available.
- Moren H, Malmsjo M, Mortensen J, Ohrstrom A. Riboflavin and ultraviolet a collagen crosslinking of the cornea for the treatment of keratitis. Cornea. 2010 Jan;29(1):102-4. doi: 10.1097/ICO.0b013e31819c4e43.
- Anwar HM, El-Danasoury AM, Hashem AN. Corneal collagen crosslinking in the treatment of infectious keratitis. Clin Ophthalmol. 2011;5:1277-80. doi: 10.2147/OPTH.S24532. Epub 2011 Sep 7.
- Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.
- Alio JL, Abbouda A, Valle DD, Del Castillo JM, Fernandez JA. Corneal cross linking and infectious keratitis: a systematic review with a meta-analysis of reported cases. J Ophthalmic Inflamm Infect. 2013 May 29;3(1):47. doi: 10.1186/1869-5760-3-47.
- Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEI-2015/01/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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