Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates
NCT ID: NCT03844178
Last Updated: 2019-02-18
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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UNKNOWN
PHASE2
104 participants
INTERVENTIONAL
2019-02-10
2019-07-01
Brief Summary
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Surgical Technique The same surgeon (A.F.) will perform all surgeries. After installation of Tetracaine 1%, periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. In the right eye of each patient PCS compensation will be turned on (PCS-On group) and in the left eye it will be turned off (PCS-Off group). Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA). Selection of which eye to be first ablated will be done randomly. Randomization will be performed based on a computer software by a Biostatistician which produced the first eye to be operated. Static cyclotorsion compensation will be active in all eyes. The ablation profile will be wavefront-optimized in all cases.
Postoperative Course Postoperatively, chloramphenicol 0.5% eye drops and betamethasone 0.1% eye drops will be prescribed every 6 hours for 10 days. Thereafter, Fluorometholone 0.1% eye drops every 6 hours for 1 month and every 8 hours for the next month will be given. Follow-up examinations were scheduled at 1, 2, 3, 4, 7 and 15 days and 1, 2, 3, and 6 months postoperatively. After contact lens removal each follow-up examination includes the UDVA, manifest refraction, and IOP measurements as well as a slit lamp biomicroscopy. Corneal imaging with Galilei tomography, CDVA and cyclorefraction will be performed at the final follow-up examination 6 months postoperatively.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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The right eyes with compensation for Pupil centroid shift
The option for compensation of Pupil centroid shift was ON
The option for compensation of Pupil centroid shift was ON
installation of Tetracaine 1%
installation of Tetracaine 1%
Photorefractive keratectomy (PRK)
periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA)
The left eyes without compensation for Pupil centroid shift
The option for compensation of Pupil centroid shift was OFF
The option for compensation of Pupil centroid shift was OFF
installation of Tetracaine 1%
installation of Tetracaine 1%
Photorefractive keratectomy (PRK)
periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA)
Interventions
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The option for compensation of Pupil centroid shift was ON
The option for compensation of Pupil centroid shift was ON
The option for compensation of Pupil centroid shift was OFF
The option for compensation of Pupil centroid shift was OFF
installation of Tetracaine 1%
installation of Tetracaine 1%
Photorefractive keratectomy (PRK)
periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA)
Eligibility Criteria
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Inclusion Criteria
* myopic astigmatism
Exclusion Criteria
* corneal opacity
* keratoconus, keratoconus suspects
* residual corneal stromal thickness less than 350 µm
* moderate or severe dry eye disease
* any other ocular pathology other than refractive error
18 Years
40 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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97362
Identifier Type: -
Identifier Source: org_study_id
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