Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus (keratoconus)
Primary Purpose
Keratoconus
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Photorefractive keratectomy in mile keratoconus
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
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
Sites / Locations
- Farideh Doroodgar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photorefractive keratectomy in mile keratoconus
Arm Description
Photorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error
Outcomes
Primary Outcome Measures
visual acuity
Visual acuity (VA) commonly refers to the clarity of vision
Secondary Outcome Measures
Full Information
NCT ID
NCT03890718
First Posted
March 25, 2019
Last Updated
April 10, 2022
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT03890718
Brief Title
Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus
Acronym
keratoconus
Official Title
Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photorefractive keratectomy in mile keratoconus
Arm Type
Experimental
Arm Description
Photorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error
Intervention Type
Procedure
Intervention Name(s)
Photorefractive keratectomy in mile keratoconus
Other Intervention Name(s)
Advance surface abelation in mild keratoconus
Intervention Description
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
Primary Outcome Measure Information:
Title
visual acuity
Description
Visual acuity (VA) commonly refers to the clarity of vision
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Aberrometry properties by iTrace Ray-tracing aberrometry
Description
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).
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Alio, MD,PhD
Organizational Affiliation
Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Farideh Doroodgar
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus
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