Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
NCT ID: NCT04710082
Last Updated: 2021-07-20
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-06-01
2021-06-30
Brief Summary
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Detailed Description
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Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile.
Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted.
The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK
Patients planned to undergo:
1. Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step.
2. Laser Vision Correction using Excimer laser wavefront optimized technology.
Photorefractive keratectomy (PRK)
Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK.
Patients planned to undergo:
Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology.
Photorefractive keratectomy (PRK)
Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
Interventions
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Photorefractive keratectomy (PRK)
Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
Eligibility Criteria
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Inclusion Criteria
2. Myopic astigmatism up to -4 diopters
3. Corneal thinnest location ≥ 500 um and a residual stromal bed ≥ 300um.
Exclusion Criteria
2. Hyperopic patients.
3. Systemic disease that contraindicates LVC.
4. Intra- or post-operative complications.
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Abdel-Radi
Principal Investigator
Locations
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TIBA eye center
Asyut, , Egypt
Countries
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References
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Kaluzny BJ, Cieslinska I, Mosquera SA, Verma S. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction. Medicine (Baltimore). 2016 Feb;95(6):e1993. doi: 10.1097/MD.0000000000001993.
Abdel-Radi M, Shehata M, Mostafa MM, Aly MOM. Transepithelial photorefractive keratectomy: a prospective randomized comparative study between the two-step and the single-step techniques. Eye (Lond). 2023 Jun;37(8):1545-1552. doi: 10.1038/s41433-022-02174-4. Epub 2022 Jul 21.
Other Identifiers
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TEPRK
Identifier Type: -
Identifier Source: org_study_id
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