Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2023-07-05

Brief Summary

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

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Detailed Description

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Conditions

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Keratoconus Corneal Cross-Linking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Photorefractive Keratectomy with Corneal Cross-Linking

For correction of refractive error

Group Type EXPERIMENTAL

Photorefractive Keratectomy with Corneal Cross-Linking

Intervention Type PROCEDURE

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.

Interventions

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Photorefractive Keratectomy with Corneal Cross-Linking

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes