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NCT06751615: SPLEPICA
Enhancing Scleral Lens Fit With Advanced Imaging
trial in Keratoconus in 30 participants. Enrolling by invitation.
31 December 2024
Quick facts
| Lead sponsor | Fernando Fernandez Velazquez |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 December 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Spain |
Conditions studied
- Keratoconus — all drugs for Keratoconus →
- Astigmatism High — all drugs for Astigmatism High →
Sponsor
Fernando Fernandez Velazquez
Who can join
18 and older, any sex, with Keratoconus or Astigmatism High. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this experimental clinical trial is to enhance the predictability and precision of scleral lens fitting in patients with complex corneal conditions such as keratoconus, post-surgical irregularities, and severe dry eye syndrome. The main questions it aims to answer are: Can detailed sagittal height measurements obtained from the Oculus Pentacam Corneal Scleral Profile (CSP) predict the necessary adjustments for optimal scleral lens fit? Will the use of these measurements reduce the number of trial-and-error adjustments needed to achieve an ideal fit, thereby reducing chair time and improving patient satisfaction? Participants will: Undergo detailed corneal and scleral tomography using the Oculus Pentacam with the CSP strategy. Receive customized ICD 16.5 mm scleral lenses based on precise measurements of their ocular surface. Participate in follow-up assessments to evaluate the fit of the lenses and provide feedback on comfort and visual outcomes. This study focuses on a specific participant population of adults aged 18 and older who have not had success with other types of contact lenses. By leveraging advanced imaging technologies, the research aims to streamline the fitting process for scleral lenses, potentially setting new standards for treatment efficacy in specialty contact lens practices.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06751615
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Keratoconus
Currently open trials in the same condition.
- NCT07372911 — PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus · NA · recruiting
- NCT07461129 — Electrophysiological Changes in Cases of Different Stages of Keratoconus · active not recruiting
- NCT06601101 — Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus · Phase 3 · recruiting
- NCT05516004 — Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning · Phase 2 · recruiting
- NCT06798779 — Predicting Manifest Astigmatism in Keratoconus Patients. · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06751615 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fernando Fernandez Velazquez
- Last refreshed: 30 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06751615.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing