Customised topographic photorefractive keratectomy (PRK) followed by corneal cross-linking in a single procedure for progressive keratoconus

ISRCTN	ISRCTN57262986
DOI	https://doi.org/10.1186/ISRCTN57262986
Secondary identifying numbers	N/A

Submission date: 22/12/2009
Registration date: 18/02/2010
Last edited: 18/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Giovanni Alessio
Scientific

Piazza Giulio Cesare 11
Bari
70124
Italy

Study information

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
Participant information sheet	Non available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	08/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key 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
Key exclusion criteria	1. Corneal thinnest point less than 450 micra 2. History of ocular morbidity 3. Previous ocular surgery
Date of first enrolment	26/06/2008
Date of final enrolment	08/01/2011

Locations

Countries of recruitment

Italy

Study participating centre

Piazza Giulio Cesare 11

Bari
70124
Italy

Sponsor information

Azienda Ospedaliera Policlinico di Bari (Italy)
Hospital/treatment centre

c/o Giovanni Alessio
Department of Ophthalmology
Piazza Giulio Cesare, 11
Bari
70124
Italy

Website	http://www.policlinico.ba.it/sito/index.php
"ROR"	https://ror.org/00pap0267

Funders

Funder type

Hospital/treatment centre

Azienda Ospedaliera Policlinico di Bari (Italy) - Department of Ophthalmology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan