Topography Versus Non-Topography-Guided PRK With CXL in 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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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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

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Photorefractive keratectomy in mile keratoconus

Photorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error

Group Type EXPERIMENTAL

Photorefractive keratectomy in mile keratoconus

Intervention Type PROCEDURE

Topo-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

Interventions

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Photorefractive keratectomy in mile keratoconus

Topo-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

Intervention Type PROCEDURE

Other Intervention Names

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Advance surface abelation in mild keratoconus

Eligibility Criteria

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Inclusion Criteria

* age 34 (range from 34 to 41)
* stable corneal topography and refraction for at least six months
* estimated residual bed thickness of \>410 µm

Exclusion

* 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
* lactation

Minimum Eligible Age

34 Years

Maximum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes