Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 11, 2025
November 1, 2025
12 months
November 28, 2025
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
visual acuity improvement measured by LogMAR system
visual acuity improvement measured by LogMAR system
1 year
Study Arms (2)
PRK PLUS
EXPERIMENTALPRK PLUS
Follow up group
NO INTERVENTIONfollow up with pentacam
Interventions
therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking
Eligibility Criteria
You may qualify if:
- CCT less than 490 microns
- K mean more than 46 and/or K max more than 47.
- Astigmatism cylinder \>1.5 D.
- D value of Belin/Ambrósio Module \> 1.6
- inferior- superior asymmetry or bow-tie pattern with skewed radial axes on tangential maps and abnormal changes on (BAD).
- Asymmetry topography between 2 eyes, even if neither eye"s topographic pattern is in itself decidedly abnormal.
- Any significant skewed radial axis with or without inferior steepening, or one diopter or more of inferior steepening in some areas but an I-S value of ,1.4,7.
- young patients with against-the-rule astigmatic patterns.
- a PTA value 40% if calculated.
- Abnormal Topographic Patterns
- K2 reading of corneal back surface less than \[-7\].
- D Value of CSTP \> 2.5 in Belin/Ambrósio curve
- We look at values within the central 5 mm circle; the map should be displayed in the BFTE float mode with an estimated area of 8 mm of diameter:
- Elevation values on the front surface values \> +12 μ
- Elevation values on the back surface values \>+15 μ.
- +1 more criteria
You may not qualify if:
- Eyes diagnosed with KC.
- CCT less than 450 microns
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 28, 2025
First Posted
December 11, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
December 11, 2025
Record last verified: 2025-11