NCT07277348

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2026

Status
not yet recruiting

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

Study Progress24%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

November 28, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

November 28, 2025

Last Update Submit

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

EXPERIMENTAL

PRK PLUS

Procedure: PRK PLUS

Follow up group

NO INTERVENTION

follow up with pentacam

Interventions

PRK PLUSPROCEDURE

therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking

PRK PLUS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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