Clinical Trials Directory

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UnknownNCT03890718

Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus

Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
38 (estimated)
Sponsor
Shahid Beheshti University · Academic / Other
Sex
All
Age
34 Years – 41 Years
Healthy volunteers
Accepted

Summary

To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.

Detailed description

Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) were divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures were pre- and postoperative uncorrected distance visual acuity (UDVA), best corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry.

Conditions

Interventions

TypeNameDescription
PROCEDUREPhotorefractive keratectomy in mile keratoconusTopo-guided photorefractive keratectomy will be performed using an excimer laser (Allegretto Wave Topolyzer, Alcon, Inc.) with a 6 mm optical area and a transition area of 2 mm in all eyes. At that point, the partial topography-guided photorefractive keratectomy laser treatment will be finished. The arrangement will be to treat 70% of the cylindrical and spherical part to not surpass 50μm of stromal expulsion. The estimation of 50μm as the most extreme removal depth recommended by Kanellopoulos in Athens protocol will be chosen

Timeline

Start date
2017-03-30
Primary completion
2022-09-30
Completion
2023-12-15
First posted
2019-03-26
Last updated
2022-04-18

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT03890718. Inclusion in this directory is not an endorsement.