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Not yet recruiting NCT07277348

Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea

No phase Interventional Thin Suspicious Cornea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRK PLUS.
Who it may be relevant to
Registry conditions: Thin Suspicious Cornea. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious Cornea: Short-Term Pilot Study

Overview

analyze the outcomes of therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking (PRK-Plus), for treatment of thin suspicious cornea

Interventions

  • Procedure PRK PLUS
    therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking

Primary outcome measures

  • visual acuity improvement measured by LogMAR system [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.
  • If there is any isolated island on either front or back surfaces (in the BFS float mode)

Exclusion criteria

  • Eyes diagnosed with KC.
  • CCT less than 450 microns

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07277348 · PRK PLUS in thin cornea

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗