Combining two treatments for keratoconus to improve vision
Official title: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
Run by Oslo University Hospital · NCT06264024 · Data updated 2026-11-12
This study is testing if combining two treatments for keratoconus can help improve vision more than just one treatment alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 81 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | February 12, 2024 |
| Main results expected | May 1, 2025 |
| Study ends | February 1, 2034 |
| Registry record updated | February 16, 2024 |
| Trial ID | NCT06264024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with progressive keratoconus who meet specific corneal thickness criteria.
✕Probably not a fit
Patients with other eye diseases that cause visual impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar combined treatment approaches, suggesting potential for success in this trial.
Who can join: the full rules
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 it's running
-
Department of Ophhtalmology, University of Oslo
Oslo, Norway Recruiting
Study contacts
- Study coordinator: Olav Kristianslund, MD, PhD
- Email: olakri@ous-hf.no
- Phone: +4722118545
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia
This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.
-
Brillouin hydration mapping to study cornea health
Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.
-
Same-day bilateral corneal cross-linking for keratoconus
This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.
-
A Smart Aperture Lens to Help Keratoconus and Presbyopia
This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.
-
GLK-221 eye drops for keratoconus
This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.
-
Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus
This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.