Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
Ethics approval(s)
Local Ethics Committee of Azienda Ospedaliera Policlinico di Bari approved on the 18th June 2008
Study design
Prospective non-randomised single centre trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Non available in web format, please use the contact details below to request a patient information sheet
Condition
Keratoconus
Intervention
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.
Intervention type
Other
Primary outcome measure
Measured at 1, 3, 6, 12, and 18 months:
1. Visual acuity
2. Refraction
3. Corneal aberrations
4. Corneal topography
Secondary outcome measures
Measured at 1, 3, 6, 12, and 18 months:
1. Confocal microscopy
2. Anterior segment optical coherence tomography
Overall study start date
26/06/2008
Overall study end date
08/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
20
Participant exclusion criteria
1. Corneal thinnest point less than 450 micra
2. History of ocular morbidity
3. Previous ocular surgery
Recruitment start date
26/06/2008
Recruitment end date
08/01/2011
Locations
Countries of recruitment
Italy
Study participating centre
Piazza Giulio Cesare 11
Bari
70124
Italy
Sponsor information
Organisation
Azienda Ospedaliera Policlinico di Bari (Italy)
Sponsor details
c/o Giovanni Alessio
Department of Ophthalmology
Piazza Giulio Cesare
11
Bari
70124
Italy
Sponsor type
Hospital/treatment centre
Website
http://www.policlinico.ba.it/sito/index.php
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Azienda Ospedaliera Policlinico di Bari (Italy) - Department of Ophthalmology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|