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Preoperative Corneal Measurements Estimate the Corrected Distance Visual Acuity After Corneal Cross-linking

NCT06522789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-07-30

No results posted yet for this study

Summary

This study aims to determine if objective markers describing corneal optical density (COD), thinnest corneal thickness (TCT), anterior (ARC), and posterior (PRC) surface radii over the 3mm thinnest region of the cornea could provide a model for calculating corrected distance visual acuity (CDVA) after corneal cross-linking (CXL) in keratoconus.

Conditions

  • Keratoconus

Interventions

PROCEDURE

corneal cross-linking procedure

Standard Dresden protocol corneal cross-linking procedure The CXL procedure adhered to the standard Dresden protocol. All patients received topical anaesthetic (Tetracaine HCL 0.5%, Alcon Forth Worth, Texas) and a miotic (Isopto Carpine 2% HCl, Alcon, Fort Worth, Texas) drops 30 minutes before the procedure. The periocular region and conjunctival sac were washed with 10% povidone-iodine (Betadine 10%, Alcaloid, Skopje). Manual epithelial scraping with a crescent knife followed. Pachymetry was kept over 400 μm during the procedure and measured with an ultrasound hand pachymeter (Pocket II, Quantel Medical, Cournon d'Auvergne, France). Riboflavin (Peschke D, Peschke Trade, Huenenberg, Switzerland) was applied every 3 minutes for 30 minutes. We performed corneal UV-A radiation with a wavelength of 370 nm and energy of 3mW using a UVA CXL lamp (VEGA CBM-X-Linker, Carleton Optical, Chesham, UK) for 30 minutes (6 cycles of 5 minutes each).

Sponsors & Collaborators

  • Sistina Ophthalmology Hospital

    lead OTHER

Principal Investigators

  • Fanka Gilevska, PhD cand · Sistina Ophthalmology Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2022-07-30
Completion
2023-07-30

Countries

  • North Macedonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522789 on ClinicalTrials.gov