Sponsor study identifier
interventional
54
1 country
1
Study Start
August 30, 2018
Actual (reported)Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the cornea. When the eye is healthy, these ulcers typically heal rapidly. However, when there is an underlying disease such as diabetes, this healing process is altered and it takes longer for the ulcer to heal. Autologous platelet-rich plasma (PRP) is a substance that is obtained from the patient's own blood and it is believed this substance may replace those missing factors in the tears of patients with PED. The purpose of this investigation is to find out whether PRP combined with a bandage contact lens is better than preservative free lubricant combined with bandage contact lens or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and will get the treatment until the ulcer heals completely. We will count the days it takes for the PED to heal and based on that we will determine wich treatment is more effective (the treatment that takes the least days to heal will be considered the most effective). Since this disease is difficult to treat and doesn't have a gold standard treatment, usually the available treatments are not as good as we would like, therefore, the ulcer might progress even to perforation regardless of the treatment. In these cases, we will provide appropriate treatment for progressive corneal thinning and corneal perforation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2018
Actual (reported)August 30, 2018
Actual (reported)August 31, 2018
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Persistent epithelial defect healing time.
Persistent epithelial defect healing time measured in days.
From the first day of treatment until the date of complete defect closure, assessed up to 3 months.
Change in corneal sensitivity
Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.
Uncorrected visual acuity
Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Best corrected visual acuity
Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular pain
Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Ocular surface symptoms
Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
Eye patch plus ocular lubricant ointment every 24 hours.
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. Ophthalmology. 1999 Oct;106(10):1984-9. doi: 10.1016/S0161-6420(99)90412-8.
Chen J, Chen P, Backman LJ, Zhou Q, Danielson P. Ciliary Neurotrophic Factor Promotes the Migration of Corneal Epithelial Stem/progenitor Cells by Up-regulation of MMPs through the Phosphorylation of Akt. Sci Rep. 2016 May 13;6:25870. doi: 10.1038/srep25870.
Karim Mohamed-Noriega, M.D.
Hospital Universitario Dr. Jose E. Gonzalez
First Submitted
August 16, 2018
First Posted
August 31, 2018
Study Start
Eye patch plus ocular lubricant ointment every 24 hours.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Ljubimov AV, Saghizadeh M. Progress in corneal wound healing. Prog Retin Eye Res. 2015 Nov;49:17-45. doi: 10.1016/j.preteyeres.2015.07.002. Epub 2015 Jul 18.
Nugent RB, Lee GA. Ophthalmic use of blood-derived products. Surv Ophthalmol. 2015 Sep-Oct;60(5):406-34. doi: 10.1016/j.survophthal.2015.03.003. Epub 2015 Apr 15.
Alio JL, Rodriguez AE, WrobelDudzinska D. Eye platelet-rich plasma in the treatment of ocular surface disorders. Curr Opin Ophthalmol. 2015 Jul;26(4):325-32. doi: 10.1097/ICU.0000000000000169.
Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
August 30, 2018
Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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