Combining two treatments for keratoconus to improve vision
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
This study is testing if combining two treatments for keratoconus can help improve vision more than just one treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06264024 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of corneal collagen cross-linking (CXL) alone versus a combined treatment of CXL and transepithelial phototherapeutic keratectomy (t-PTK) in patients with keratoconus. The study will evaluate whether the combined approach can lead to better visual acuity while ensuring safety for the patients. Participants will be randomly assigned to receive either treatment, and their outcomes will be monitored to assess the benefits of the combined therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with progressive keratoconus who meet specific corneal thickness criteria.
Not a fit: Patients with other eye diseases that cause visual impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with improved vision and better treatment options for keratoconus.
How similar studies have performed: Other studies have shown promising results with similar combined treatment approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit. * Progressive keratoconus with indication for CXL * Corneal thickness ≥ 420 μm Exclusion Criteria: * Other eye disease causing visual impairment
Where this trial is running
Oslo
- Department of Ophhtalmology, University of Oslo — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Olav Kristianslund, MD, PhD
- Email: olakri@ous-hf.no
- Phone: +4722118545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.