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Customised topographic photorefractive keratectomy (PRK) followed by corneal cross-linking in a single procedure for progressive keratoconus
ISRCTN ISRCTN57262986
DOI 10.1186/ISRCTN57262986
ClinicalTrials.gov identifier
EudraCT number
Public title Customised topographic photorefractive keratectomy (PRK) followed by corneal cross-linking in a single procedure for progressive keratoconus
Scientific title 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
Acronym N/A
Serial number at source N/A
Study hypothesis Cross linking is a well established procedure to halt the progression of keratoconus. Customised topographic photorefractive keratectomy (PRK) worked well in the correction of irregular astigmatism. The combination of these two procedures should be a valuable tool for both the correction of corneal irregularity and the prevention of progression in case of progressive keratoconus.
Lay summary
Ethics approval Local Ethics Committee of Azienda Ospedaliera Policlinico di Bari approved on the 18th June 2008
Study design Prospective non-randomised single centre trial
Countries of recruitment Italy
Disease/condition/study domain Keratoconus
Participants - 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
Participants - exclusion criteria 1. Corneal thinnest point less than 450 micra
2. History of ocular morbidity
3. Previous ocular surgery
Anticipated start date 26/06/2008
Anticipated end date 08/01/2011
Status of trial Completed
Patient information material Non available in web format, please use the contact details below to request a patient information sheet
Target number of participants 20
Interventions 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.
Primary outcome measure(s) Measured at 1, 3, 6, 12, and 18 months:
1. Visual acuity
2. Refraction
3. Corneal aberrations
4. Corneal topography
Secondary outcome measure(s) Measured at 1, 3, 6, 12, and 18 months:
1. Confocal microscopy
2. Anterior segment optical coherence tomography
Sources of funding Azienda Ospedaliera Policlinico di Bari (Italy) - Department of Ophthalmology
Trial website
Publications
Contact name Prof  Giovanni  Alessio
  Address Piazza Giulio Cesare 11
  City/town Bari
  Zip/Postcode 70124
  Country Italy
Sponsor Azienda Ospedaliera Policlinico di Bari (Italy)
  Address c/o Giovanni Alessio
Department of Ophthalmology
Piazza Giulio Cesare, 11
  City/town Bari
  Zip/Postcode 70124
  Country Italy
  Sponsor website: http://www.policlinico.ba.it/sito/index.php
Date applied 22/12/2009
Last edited 18/02/2010
Date ISRCTN assigned 18/02/2010
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