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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thin Suspicious Cornea
• Intervention / Treatment: Procedure: PRK PLUS

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. CCT less than 490 microns
2. K mean more than 46 and/or K max more than 47.
3. Astigmatism cylinder >1.5 D.
4. D value of Belin/Ambrósio Module > 1.6
5. inferior- superior asymmetry or bow-tie pattern with skewed radial axes on tangential maps and abnormal changes on (BAD).
6. Asymmetry topography between 2 eyes, even if neither eye"s topographic pattern is in itself decidedly abnormal.
7. 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.
8. young patients with against-the-rule astigmatic patterns.
9. a PTA value 40% if calculated.
10. Abnormal Topographic Patterns
11. K2 reading of corneal back surface less than [-7].
12. D Value of CSTP > 2.5 in Belin/Ambrósio curve

13. 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:

1. Eyes diagnosed with KC.
2. CCT less than 450 microns

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRK PLUS	Procedure: PRK PLUS; therapeutic photorefractive keratectomy combined with prophylactic accelerated cross-linking
No Intervention: Follow up group; follow up with pentacam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity improvement measured by LogMAR system	visual acuity improvement measured by LogMAR system	1 year

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PRK PLUS in thin cornea

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No