Condition category
Eye Diseases
Date applied
22/12/2009
Date assigned
18/02/2010
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giovanni Alessio

ORCID ID

Contact details

Piazza Giulio Cesare 11
Bari
70124
Italy

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

26/06/2008

Overall trial end date

08/01/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes