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NCT02857881: KERADES
Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus
NA trial testing De-epithelization and therapeutic photokeratectomy in Keratoconus in 20 participants. Terminated before completion.
7 February 2019
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 13 October 2015 |
| Primary completion | 7 February 2019 |
| Estimated completion | 7 February 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- De-epithelization and therapeutic photokeratectomy
Conditions studied
- Keratoconus — all drugs for Keratoconus →
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild — full company profile →
Who can join
Adults 15 to 45, any sex, with Keratoconus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology, characterized by a progressive corneal thinning. This disease leads to a bombing of the cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL) and simple corneal de-epithelization are two common surgical technics aiming to slow the progression of this pathology. They consist in rigidifying the corneal structure in order to stabilize its deformation progression. Even though these technics are commonly performed, none of these strategies has proven their efficiency. The effects of CXL can be due to the superficial scarring reaction as well as the effects of corneal remodeling induced by the de-epithelization phase during a CXL procedure, and not due to the covalent links between collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition in the presence of Riboflavine De-epithelization may be an equally effective treatment, when compared to CXL, but without long term secondary effects. Its association with a therapeutic photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate its opacities in order to recuperate the transparency of the cornea) will aim to improve the regularity of the anterior corneal surface, thus allowing a better epithelial attachment (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency in the treatment of keratoconus. The purpose of this study is to describe the effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1 year, after an intervention of de-epithelization associated with therapeutic photokeratectomy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02857881
- Europe PMC full search
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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
Other Fondation Ophtalmologique Adolphe de Rothschild trials
Trials by the same sponsor.
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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 NCT02857881 (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 Fondation Ophtalmologique Adolphe de Rothschild
- Last refreshed: 11 June 2019
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/NCT02857881.
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