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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN57262986 |
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Date of registration:
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18/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Customised topographic photorefractive keratectomy (PRK) followed by corneal cross-linking in a single procedure for progressive keratoconus
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Scientific title:
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Comparison of cross linking alone and customised photorefractive keratectomy (PRK) followed by cross linking in the treatment of progressive keratoconus: a prospective non-randomised single centre trial |
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Date of first enrolment:
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26/06/2008 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN57262986 |
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Study type:
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Interventional |
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Study design:
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Prospective non-randomised single centre trial (Treatment)
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Giovanni
Alessio |
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Address:
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Piazza Giulio Cesare 11
70124
Bari
Italy |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Documented progressive keratoconus
2. Corneal thinnest point: 450 micra
3. Hard contact lens and full spectacle correction intolerance
4. Aged over 18 years, either sex
Exclusion criteria: 1. Corneal thinnest point less than 450 micra
2. History of ocular morbidity
3. Previous ocular surgery
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Keratoconus
Eye Diseases
Other disorders of cornea
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Intervention(s)
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Customised topographic PRK and corneal cross-linking in a single procedure are performed in the worse keratoconic eye, while routine cross linking is performed on the fellow eye.
The treatment lasts about 55 minutes (about 30 seconds for PRK and 50 minutes for cross-linking procedure). The duration of follow-up is 18 months.
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Primary Outcome(s)
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Measured at 1, 3, 6, 12, and 18 months:
1. Visual acuity
2. Refraction
3. Corneal aberrations
4. Corneal topography
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Secondary Outcome(s)
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Measured at 1, 3, 6, 12, and 18 months:
1. Confocal microscopy
2. Anterior segment optical coherence tomography
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Source(s) of Monetary Support
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Azienda Ospedaliera Policlinico di Bari (Italy) - Department of Ophthalmology
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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