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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57262986
Enrollment
20
Registered
2010-02-18
Start date
2008-06-26
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus Eye Diseases Other disorders of cornea

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

Sponsors

Azienda Ospedaliera Policlinico di Bari (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Corneal thinnest point less than 450 micra 2. History of ocular morbidity 3. Previous ocular surgery

Design outcomes

Primary

MeasureTime frame
Measured at 1, 3, 6, 12, and 18 months: 1. Visual acuity 2. Refraction 3. Corneal aberrations 4. Corneal topography

Secondary

MeasureTime frame
Measured at 1, 3, 6, 12, and 18 months: 1. Confocal microscopy 2. Anterior segment optical coherence tomography

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026