Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
NCT ID: NCT05019768
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2017-09-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sCXL
Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes
Standard CXL
The standard CXL procedure has been carried on following the Dresden protocol
aCFXL
Accelerated custom fast CXL protocol. The protocol has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin con-sumption rate and the corneal thickness at its thinnest point.
Riboflavin-VEPTGS solution: Epithelial lavage before UV UVA fluence of 1.8 ±0.9 mW/cm2 UVA Irradiation time 10 ± 1.5 minutes
accelerated custom-fast CXL
The accelerated custom fast CXL (aCFXL) has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin consumption rate and the corneal thickness at its thinnest point. By knowing both values, the mathematical model allows to objectively calculate both the exact UVA irradiation value (intensity), expressed in mW/cm2, and the irradiation time
Interventions
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accelerated custom-fast CXL
The accelerated custom fast CXL (aCFXL) has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin consumption rate and the corneal thickness at its thinnest point. By knowing both values, the mathematical model allows to objectively calculate both the exact UVA irradiation value (intensity), expressed in mW/cm2, and the irradiation time
Standard CXL
The standard CXL procedure has been carried on following the Dresden protocol
Eligibility Criteria
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Inclusion Criteria
* changes in uncorrected distance visual acuity (UDVA) above 1.00 D
* Corrected distance visual acuity (BCVA) above 1.00 D
* spherical equivalent greater than 0.50 D
Exclusion Criteria
* less than 2000 cells/cm2,
* corneal scarring,
* nystagmus or any motility disorder that prevented a fixed gaze during the examination
* Current contact lens use
18 Years
ALL
No
Sponsors
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Ciro Caruso
OTHER
Responsible Party
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Ciro Caruso
MD, Head of Corneal Transplant Center
Locations
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Pellegrini Hospital
Napoli, , Italy
Countries
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References
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Caruso C, Ostacolo C, Epstein RL, Barbaro G, Troisi S, Capobianco D. Transepithelial Corneal Cross-Linking With Vitamin E-Enhanced Riboflavin Solution and Abbreviated, Low-Dose UV-A: 24-Month Clinical Outcomes. Cornea. 2016 Feb;35(2):145-50. doi: 10.1097/ICO.0000000000000699.
Caruso C, Epstein RL, Ostacolo C, Pacente L, Troisi S, Barbaro G. Customized Corneal Cross-Linking-A Mathematical Model. Cornea. 2017 May;36(5):600-604. doi: 10.1097/ICO.0000000000001160.
Other Identifiers
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127
Identifier Type: -
Identifier Source: org_study_id
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