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 |
| Protocol serial number | N/A |
| Sponsor | Azienda Ospedaliera Policlinico di Bari (Italy) |
| Funder | Azienda Ospedaliera Policlinico di Bari (Italy) - Department of Ophthalmology |
- 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
Scientific
Piazza Giulio Cesare 11
Bari
70124
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-randomised single centre trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Measured at 1, 3, 6, 12, and 18 months: |
| Key secondary outcome measure(s) |
Measured at 1, 3, 6, 12, and 18 months: |
| Completion date | 08/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
70124
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
