Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus
NCT ID: NCT06159881
Last Updated: 2023-12-07
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-03-01
2024-05-15
Brief Summary
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* Is it effective while using personalized (reduced) energy?
* Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Personalized cross linking
Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry
Corneal Cross Linking
Total fluence adapted to thinnest point pachymetry
Interventions
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Corneal Cross Linking
Total fluence adapted to thinnest point pachymetry
Eligibility Criteria
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Inclusion Criteria
* Thinnest point pachymetry below 400 microns
Exclusion Criteria
* Corneal scars not allowing best corrected visual acuity of 20/100 or better
* Previous corneal hydrops history
* Psychomotor retardation history
18 Years
ALL
No
Sponsors
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Instituto de Oftalmología Fundación Conde de Valenciana
OTHER
Responsible Party
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Principal Investigators
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Enrique Graue, MD, MSc
Role: STUDY_DIRECTOR
Instituto de Oftalmología Conde de Valenciana
Locations
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Instituto de Oftalmología Conde de Valenciana
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Enrique Graue
Role: primary
References
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Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA. Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30.
Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB. Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878.
Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG. Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28.
Other Identifiers
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17 CI 09 015 008
Identifier Type: -
Identifier Source: org_study_id