Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus
keratoconus
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedApril 18, 2022
January 1, 2022
5.5 years
March 25, 2019
April 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
visual acuity
Visual acuity (VA) commonly refers to the clarity of vision
3 months
Other Outcomes (1)
Aberrometry properties by iTrace Ray-tracing aberrometry
3 year
Study Arms (1)
Photorefractive keratectomy in mile keratoconus
EXPERIMENTALPhotorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error
Interventions
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
Eligibility Criteria
You may qualify if:
- age 34 (range from 34 to 41)
- stable corneal topography and refraction for at least six months
- estimated residual bed thickness of \>410 µm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Farideh Doroodgar
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jorge Alio, MD,PhD
Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 26, 2019
Study Start
March 30, 2017
Primary Completion
September 30, 2022
Study Completion
December 15, 2023
Last Updated
April 18, 2022
Record last verified: 2022-01