- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890718
Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus (keratoconus)
April 10, 2022 updated by: farinaz doroodgar, Shahid Beheshti University
Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Farideh Doroodgar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years to 41 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Photorefractive keratectomy in mile keratoconus
Photorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual acuity
Time Frame: 3 months
|
Visual acuity (VA) commonly refers to the clarity of vision
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3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aberrometry properties by iTrace Ray-tracing aberrometry
Time Frame: 3 year
|
Optical aberrations are a major cause for poor quality of vision.
It occurs when light from one point, after transmission through an optical system, does not converge to or diverge from a single point.
Any deviation of the optical system from paraxial optics results in aberrations.
In the eye, the various refracting surfaces like tear film, cornea and lens are primarily responsible for inducing ocular aberrations.
The difference in shape of the wave-front entering the eye and that exiting the eye defines the type of aberration.
The ocular aberrations are classified into lower order aberration (LOA) (zero order- piston; first order- horizontal and vertical tilt; second order- spherical defocus and astigmatism) and higher order aberrations (HOA) (third order - coma and trefoil; fourth order - quatrefoil, secondary astigmatism and spherical aberrations; fifth order - pentafoil; sixth order - hexafoil).
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3 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jorge Alio, MD,PhD, Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2017
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
December 15, 2023
Study Registration Dates
First Submitted
March 25, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShaheidBU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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